Scientist I, Quality Control LTS

Operator III, Packaging - 2nd Shift

Process Engineering Manager

Project Manufacturing Leader

Business Strategy Analyst

Chemist Data Reviewer

Supervisor-Manufacturing Process Development Engineer

Facility Engineering - Electrical / Mechanical

Microbiology Technician

Demand Analyst 

Role Description: <ul><li>The Scientist, Laboratory Technical Services is primarily responsible for supporting the analytical testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. </li><li>Has expert proficiency in conducting all types of physical and chemical analysis (including the most complex analysis) using all equipment. </li><li>This position will have a significant role supporting pending ANDA submissions, product launches, and method lifecycle activities to achieve company goals and initiatives. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Chemist.</li></ul> Responisbilities: Analysis &amp; Testing: <ul><li>Validate analytical methods for finished product and raw material release and stability testing.</li><li>Evaluates, troubleshoot/improves existing analytical methods when necessary.</li><li>Prepares method validation protocols, reports, and analytical test methods.</li><li>Performs testing to support process and formulation development (e.g. excipient, compatibility, solubility, dissolution studies, stability/impurity assessment)</li><li>Performs work to support project assigned with little oversight.</li><li>Presents analytical data to project team for review and discussion</li><li>Reviews and approves laboratory test data and documentation (e.g. notebooks, raw data and technical documentation, test methods, validation protocols, or validation report) for completeness and compliance when necessary</li><li>Reviews and evaluates drug substance supplier’s technical documents to ensure internal testing test requirements are adequate.</li><li>Uses laboratory software for analysis.</li><li>Is alert to and detects abnormalities during performances of test and reviews.</li></ul> Lab Equipment: <ul><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.</li><li>Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals</li><li>Troubleshoots instrumentation and performs subsequent analyses</li></ul> Investigations: <ul><li>Evaluates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action related to LTS activities</li><li>Participates in root cause identification of complex laboratory investigations.</li><li>Writes, edits, and reviews SOPs and laboratory investigations</li></ul> Training: <ul><li>Train junior Scientist/Chemists on analytical techniques.</li><li>Continuously updates knowledge with respect to the latest technologies related to analytical science</li><li>Maintains assigned training records current and in-compliance</li><li>Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures</li></ul> Compliance: <ul><li>Identifies need for SOPs and writes or revises, as appropriate</li><li>Performs work in a timely and safe manner conforming to regulatory, company and compendial requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations</li><li>Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs</li><li>Takes active role in auditing laboratory logbooks/documentation to ensure compliance</li><li>Follows internal processes related to controlled substances</li></ul> Safety: <ul><li>Follows EH&amp;S procedures to ensure a safe work environment</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS</li></ul> Requirements: Education &amp; Experience: <ul><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with 6 years’ relevant analytical laboratory experience OR</li><li>Master’s degree in above disciplines with 4 years’ relevant analytical lab experience OR</li><li>PhD in above disciplines with some relevant analytical laboratory experience preferred</li></ul> Knowledge &amp; Skills: <ul><li>Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports.</li><li>Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.</li><li>Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS</li><li>Has demonstrated competence in conducting chemical analyses</li><li>Strong knowledge of wet chemistry techniques</li><li>Competency in Microsoft Office Suite</li><li>Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information</li><li>Ability to display and analyze data in a logical manner</li><li>Strong verbal and written communication skills as well as good computer skills</li><li>Strong attention to details and accurate record keeping</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills</li><li>Ability to coach less senior staff and develop laboratory skills and ability</li><li>Ability to take initiative, set priorities and follow through on assignments</li></ul> Physical Requirements: <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Role Description: <ul><li>With thorough knowledge and skills in all areas of the packaging process, performs more advanced functions relating to the packaging of drug products consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). Is qualified in both Filling and Labeling. </li><li>Is qualified and capable of competently running all packaging equipment across the entire packaging department. </li><li>Responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards. May serve as back-up to the Senior Packaging Technician.</li></ul> Responsibilities: Packaging Operations: <ul><li>Is qualified and capable of competently running all packaging equipment across the entire packaging department</li><li>Is qualified in both Filling and Labeling</li><li>Ensures that all equipment is running properly</li><li>Executes processes such as material handling, capping, outserts/med guides, in-process checks, packing, stacking, cartooning, etc.</li><li>May request components, labels and inserts per the BPR</li><li>Sets up packaging machinery; accurately sets equipment programming according to BPRs and SOPs</li><li>Sets up, starts, operates, adjusts, troubleshoots and tears down packaging lines</li><li>Executes Batch Production Record (BPR) and logbook documentation with detail and accuracy</li><li>Accurately reviews BPRs steps for completeness and accuracy</li><li>Collects samples from each batch and submits to QA for retained samples</li><li>Demonstrates the ability to execute procedures and complete tasks in a compliant and safe manner</li></ul> Equipment Cleaning: <ul><li>Conducts verification of line/equipment cleaning and documents per SOP</li><li>Executes the procedures used to clean pharmaceutical packaging equipment and facilities</li><li>Conducts Master Cleans and Surface Cleans</li></ul> Continuous Improvement : <ul><li>Identifies 6S opportunities and sustains the 6S process</li><li>Assists in troubleshooting process issues</li></ul> Issues and Deviations: <ul><li>Identifies and reports processing related issues to Packaging Supervisor and to Quality personnel.</li></ul> Quality: <ul><li>Executes the required in-process product quality checks and documents accurately.</li></ul> Teamwork and Collaboration: <ul><li>Demonstrates the ability to work in collaboration with others as a part of a team.</li></ul> Training: <ul><li>Stays current on SOPs and cGMPs.</li><li>May participate in training qualifier classes.</li></ul> Safety and Compliance: <ul><li>Participate in safety teams, start-up discussions, incident debriefs, etc.</li><li>Carries out processing/packaging activities safely, as required, on a daily basis.</li><li>Follows all safety and compliance procedures and participates in required training.</li><li>Adheres to all cGMP compliance/regulatory mandates and quality requirements.</li><li>Ensures compliance with SOPs, Policies and Procedures as required by Par and regulatory agencies</li></ul> Misc.: <ul><li>Other related duties as assigned to meet departmental and Company objectives.</li></ul> Requirements: Education &amp; Experience: <ul><li>High school diploma or equivalent.</li><li>3 years of packaging experience</li></ul> Knowledge &amp; Skills: <ul><li>Knowledge of cGMP regulations and processes.</li><li>Qualified in both Filling and Labeling</li><li>Qualified and capable of setting up and running all machinery in the value stream</li><li>Competent in Master Clean/Surface Clean</li><li>Ability to sample batches</li><li>Ability to follow both verbal and written instructions including SOP’s and Batch Record documentation</li><li>Ability to accurately and precisely record data and batch information</li><li>Ability to work in both independent and team environments</li><li>May become a certified trainer and provide certified training in one process</li><li>Effectively interfaces with other department personnel if Senior level (4th level) isn’t available</li><li>Ability to troubleshoot process issues</li><li>Ability to Identify 6S opportunities and sustain the 6S process</li><li>Ability to participate in Continuous Improvement projects</li><li>Proficient in reading and writing English to understand work instructions and document results</li></ul> Physical Requirements: <ul><li>Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.</li><li>Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.</li><li>Vision - ability to see details at close range (within a few feet of the observer).</li><li>Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing.</li></ul>

Responsibilities: <ul><li>Own and lead the process engineering function for cleanroom assembly, end-of-line test and pre-packing, ensuring safe, compliant and capable processes that meet cost, quality, safety and delivery targets.</li><li>Define department objectives, KPI dashboard and governance (e.g., NPI definition and handover lead times, first pass yields, failure rates, quality qppm) and drive execution through standard routines and reviews.</li><li>Lead, coach and develop a team of process engineers / technicians; set clear expectations, provide performance feedback, support competency development and ensure effective succession and talent retention.</li><li>Plan and manage resources (headcount, skills, priorities) to support daily manufacturing needs, escalations, and strategic projects; balance workload across product series and value streams.</li><li>Own process engineering deliverables for NPI or transfer projects: feasibility, process concept, capacity planning, industrialization roadmap, and readiness reviews to ensure on-time SOP.</li><li>Lead cross-functional collaboration with Product Design, Quality, Production, Maintenance, Supply Chain and global counterparts to deliver robust processes supported by Design for Manufacturing / Assembly / Test (DFM / DFA / DFT) improvements.</li><li>Own the strategy and budget for process equipment, tools, fixtures, testers and workstations; approve specifications, manage procurement, acceptance, validation and release to production.</li><li>Drive continuous improvement programs (CIP / Darwin) to improve throughput, cycle time, productivity and cost; support CIP events and ensure sustained gains through standardization.</li><li>Ensure effective utilization of PFMEA and other quality tools to manage and mitigate quality risks during process development, acceptance and production release.</li><li>Develop engineering procedures to govern end-to-end process engineering activities across process design, definition, industrialization, handover, sustainment and continuous improvements.&nbsp;</li><li>Ensure upkeep of process work instructions in D365 via Process Control System as per global standards, including revisioning control based on valid change management procedures.</li><li>Ensure robust management of engineering changes (ECR), process changes and deviations, including impact assessment, validation and controlled implementation.</li><li>Own 8D problem-solving governance for process-related issues, ensure timely root-cause containment / corrective and preventive actions, lessons learned, and clear communication to stakeholders.</li><li>Drive safety, ergonomics and regulatory / ISO compliance for process engineering scope; ensure safe equipment and process design through risk assessments.</li><li>Drive the sustainable deployment of state-of-the-art engineering solutions on the assembly shop floor to enhance quality control through robust error-proofing (poka‑yoke) mechanisms and digitalizations.</li><li>Act as the site focal point to align with global and process engineering counterparts on technology roadmaps, best practices and standardization.</li><li>Manage departmental reporting, change control and communication: provide clear status updates, risks and mitigation plans to operations and leadership.</li><li>Support ad hoc tasks as assigned by superior.</li></ul> Requirements: <ul><li>8–12+ years’ experience in manufacturing/precision mechanical assembly (high-mix preferred), with demonstrated ownership of end-to-end process engineering (process development/industrialization, cleaning / helium leak testing, and controlled-environment or cleanroom assembly where applicable).</li><li>Bachelor’s/Master’s degree in Mechanical, Manufacturing, Industrial Engineering or equivalent; formal training in Lean/Six Sigma and structured problem solving will be added advantage.</li><li>Proven people leadership experience (hiring, coaching, performance management) with the ability to lead technical teams and influence cross-functional stakeholders to deliver manufacturing results.</li><li>Strong written and spoken English communication skills, including the ability to produce clear technical documentation, present KPI performance, and communicate risks / mitigation to leadership.</li><li>Strong understanding of mechanical / pneumatic / electromechanical systems, process equipment and tooling, with experience defining specifications, commissioning, qualification / validation and release to production.</li><li>Demonstrated ownership and governance mindset - sets clear standards, drives disciplined execution, and maintains strong internal / external customer focus.</li><li>Strong prioritization, planning and project management skills to manage multiple workstreams (daily support, escalations, NPI, CIP) under tight timelines and resource constraints.</li><li>Strong technical acumen in quality planning processes especially in definition of process controls based on PFMEA.</li><li>Data-driven operational leadership: builds KPI dashboards, drives root-cause problem solving (8D / A3), and delivers sustained improvements in yield, throughput / cycle time and qppm.</li><li>Strong stakeholder management and change leadership - able to drive alignment across Production, Quality, Maintenance, Supply Chain and global counterparts; comfortable leading reviews and escalations.</li></ul>

Role Description: <ul><li>The Project Manufacturing Leader is a Project Core Team Member, in charge of the industrialization of all client production lines involved in a project Value Stream, across several client plant locations when applicable.</li><li>The PML is responsible for achieving key targets in terms of Industrial Timing, Capacity, Quality and Production Costs in line with the Planisware Work packages and deliverables on time completion (or Project LeanPD milestones) requirements. His/Her role is to define and implement the best Production System and line Concepts while ensuring that all client Global Auto industrial strategy and standards are followed.</li><li>PML involvement with a new project starts at RFQ, between G0 and G1 and lasts until SOP + 3 months.</li><li>The PML reports directly to the regional ME organization, to the PML Manager/Director and functionally to the Project Manager.</li></ul> Responsibilities : Design for Manufacturing : <ul><li>The PML participates in the Product Design activities led by the Product Design Engineering Team, contributing towards reaching a product design compliant with client Industrial Targets and allowing maximum Production Profitability.</li><li>He/She leads Technology and comparative studies in case of multiple options and ensures that Process Feasibility is optimal and validated by experts.</li></ul> Footprint and Make or Buy Studies: <ul><li>With the support of his management and considering inputs from the project team, the PML conducts a preliminary footprint analysis, including Make or Buy comparative Studies.</li><li>The PML submits the proposal to the Regional/Global Industrial Strategy team for final decision.</li></ul> Production System Definition: <ul><li>(Plant: Production System, Physical lay-out) In the early program Development phase, the PML organizes, leads and follows-up the Lean Industrial Design workshop activity, involving all Project and Plant Team functions, under coordination of the ME or Launch Director.</li><li>Based on the initial industrial assumptions, he/she builds the initial Plant internal Material &amp; Information Flow Diagram (MIFD)/VSM, Line lay-out, Plant lay-out with Production System and Logistics areas footprint calculations.</li><li>Before Program CER/Capex Committee Meeting, he/she leads the Tool and machine Design Workshop, out of which plant delivers the detailed</li><li>Production Line layout and Advanced VSM. Confirm the proposed Production System including traceability and conformity.</li><li>PML leads the assessment of any equipment refurbishment needs for the project relying on the appropriate internal or external experts and validate the effective equipment refurbishment timing and cost with vendors.</li><li>Job Description The PML identifies any Industrial risk, defines a back-up plan for critical processes and provides Industrial Impact on any Engineering Change Request.</li></ul> Process FMEA: <ul><li>PML participates in the definition of Key Product Characteristics (KPC) and Key Control Characteristics (KCC) He/She coordinates and leads the PFMEA methodology during program phase with active participation of Process Experts, including PLTL or Process Engineer.</li><li>Once the initial PFMEA is completed, ensure that actions are implemented with all updates included prior to handover to the Plant at Mass Production Trial (MPT).</li></ul> CER Committee: <ul><li>(Product Manager initially presenting because of Commercial discussion then Project discussion) PML ensures Capacity analyses are completed prior to adding new equipment to the project.</li><li>He/She optimizes Project Investment through Reuse, Bundling, Massification etc. He/She builds and monitors the detailed Project Investment List.</li><li>He/She prepares and leads the Project CER/Capex industrial Presentation, submitting CER request and approval follow-up after Project and Plant Managers have validated the investments.</li><li>Once CER is presented, he/she ensures timely CER submission/validation and follow-up in line with the industrial timing.</li></ul> Industrial Timing: <ul><li>PML builds, updates &amp; monitors the complete Project Industrial timing plan for tools, equipment, Packaging, traceability and associated processes to meet all internal (MPT) and external Customer milestones on time and right first time, from specification to final acceptance.</li><li>He coordinates Project Product Engineers and Supply Chain Engineers within the Project Team and track Plants readiness status in collaboration with the Plant PLTL.</li><li>The PML coordinates Traceability Implementation, Machine and tooling acceptance, tracking improvement actions with a robust PDCA where needed. Responsible to organize Tooling &amp; Equipment progress status reviews involving the plant PLTL.</li></ul> Industrial Performance <ul><li>PML defines and tracks main Industrial Performance indicators: - MMR and Work Content - Scrap Process rate - Process Capabilities - Capacity Status and Process Cycle Time, including Equipment Utilization Monitoring (data from plant) - Rework monitoring - Material Yield - Launch Costs consolidated in the Business Plan - Project Investment PML ensures that the most suited technical solutions for Project Financial KPI improvement are investigated through standard, automation, digitalization with payback analysis.</li></ul> PAC reviews: <ul><li>Reporting PML reports progress status on Manufacturing Work Packages and related program milestones. All PMLs participate in the PML -or regional ME Department weekly routine.</li></ul> Requirements: <ul><li>Masters degree in engineering, or equivalent professional experience.</li><li>Minimum 5 years of proven experience in production or industrial area preferably in automotive sector.</li><li>Strong ability to work in an international and multicultural environment with complex matrix organization. Team building and positive mindset.</li><li>Leadership with ability to interact and coordinate complex subjects with technical teams. Proactive with a vision of long-term impact and problem anticipation.</li><li>Knowledge in project management process, Quality Control tools in production, Lean Line Design.</li><li>Result oriented with strong written, verbal communication skills. Fluent English required.&nbsp;</li></ul>

Role Description: <ul><li class="ql-align-justify">The Business Strategy Analyst supports the execution of the Group’s strategic priorities, operational excellence agenda, and performance management frameworks.</li><li class="ql-align-justify">Reporting to the Strategy &amp; Operations Manager, the role provides analytical, process, and reporting support to help translate strategy into effective execution across the Group’s enabling functions and business units.</li></ul> Responsibilities: <ul><li>Strategy Execution SupportAssist in tracking progress against strategic initiatives, KPIs, and overall business objectives.</li><li>PMO &amp; Project TrackingBuild and maintain project plans, track milestones, risks, and dependencies, and ensure timely execution.</li><li>Dashboarding &amp; ReportingPrepare dashboards, MIS reports, and performance summaries for leadership and stakeholders.</li><li>Cross-Functional CoordinationWork with multiple business functions to drive alignment, follow-ups, and accountability on key initiatives.</li><li>Operational Excellence &amp; Process SupportSupport process improvement initiatives, SOP creation, and transformation projects (e.g., outsourcing, efficiency programs).</li></ul>﻿Requirements: Knowledge, Skills, Qualifications and Experience required for this Role <ul><li class="ql-align-justify">Strategy Execution &amp; Performance Support</li><li class="ql-align-justify">Operational Excellence &amp; Business Process Improvement</li><li class="ql-align-justify">Project &amp; Initiative Coordination</li><li class="ql-align-justify">Reporting, Insights &amp; Information Management</li><li class="ql-align-justify">Stakeholder, Governance &amp; Strategy Administration Support</li></ul> Experience &amp; Knowledge: <ul><li>2–4 years’ experience in business analysis, strategy, operations, consulting, finance, or process / project support roles.</li><li>Exposure to operational excellence, process improvement, PMO, or transformation environments preferred.</li><li>Working knowledge of financial statements and basic financial analysis.</li><li>Experience supporting system or process change initiatives (requirements, SOPs, UAT, or adoption tracking) is an advantage</li></ul>&nbsp;Education: <ul><li>Bachelor’s degree in Business Administration, Economics, Finance, Engineering, Information Systems, or another relevant analytical or business discipline.</li><li>A strong analytical or quantitative academic background is preferred.</li><li>Postgraduate qualifications (e.g. MBA, MSc) or professional certifications in strategy, business analysis, project management, or operational excellence (e.g. Lean, Six Sigma, PMP) are not required, but will be considered an advantage at junior level.</li></ul>

Job Summary: <ul><li>This position is dedicated to the review, verification, and assessment of analytical data generated within the Quality Control laboratory.&nbsp;</li><li>The role ensures that all laboratory documentation meets cGMP, regulatory, and internal quality standards.&nbsp;</li><li>Responsibilities do not include performing laboratory testing, operating instruments, or releasing materials or products.</li></ul> Responsiblities: <ul><li>Review complete analytical data packages generated from a wide range of QC laboratory instrumentation, including HPLC, UPLC, GC, UV?Vis, FT?IR, Dissolution, X?Ray Diffraction (XRD), pH meters, Karl Fischer, ICP-MS, and other compendial or platform - specific systems.</li><li>Verify calculations, chromatographic integrations, peak assignments, system suitability criteria, and instrument audit trails across software platforms such as Empower, ChemStation, LabSolutions, ICP?MS data systems, and dissolution software.</li><li>Assess data for compliance with approved analytical methods, compendial requirements, SOPs, and cGMP expectations, ensuring consistency across diverse analytical techniques.</li><li>Evaluate raw data outputs such as chromatograms, spectra (UV, IR), dissolution profiles, XRD patterns, elemental analysis reports, pH logs, and mass spectrometry data for accuracy and scientific soundness.</li><li>Identify discrepancies, atypical trends, integration anomalies, missing data, or potential data integrity concerns and escalate findings promptly.</li><li>Confirm that all raw data, worksheets, logbooks, electronic records, and metadata comply with ALCOA+ principles and meet internal documentation standards.</li><li>Review LIMS entries for accuracy, completeness, and proper linkage to supporting raw data and metadata.</li><li>Ensure instrument-specific parameters (e.g., wavelength accuracy for UV, calibration curves for ICP?MS, dissolution run conditions, GC column performance) are appropriately documented and meet acceptance criteria.</li></ul> Requirements: Education &amp; Experience: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years’ relevant analytical laboratory experience OR</li><li>Master’s Degree in above disciplines with 2+ years’ relevant analytical lab experience</li></ul> Knowledge: <ul><li>Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports</li><li>Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.</li><li>Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS</li><li>Has demonstrated competence in conducting chemical analyses</li><li>Strong knowledge of wet chemistry techniques</li><li>Competency in Microsoft Office Suite</li></ul> Skills &amp; Abilities: <ul><li>Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management</li><li>Ability to display and analyze data in a logical manner</li><li>Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information</li><li>Ability to display and analyze data in a logical manner</li><li>Strong verbal and written communication skills as well as good computer skills</li><li>Strong attention to details and accurate record keeping</li><li>Establish and maintain cooperative working relationships with others</li><li>Solid organizational skills</li><li>Ability to coach less senior staff and develop laboratory skills and ability</li><li>Ability to take initiative, set priorities and follow through on assignments</li></ul> Physical Requirements: <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel.&nbsp;</li><li>Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods</li></ul>

Role Description: <ul><li>Manufacturing engineer is responsible for preparing the process sheets, tool design, establish overall strategic goals &amp; objectives of Manufacturing Engineering in alignment with organizational goals.&nbsp;</li><li>This role will be an individual contributor, which reports to MGR I MFG &amp; Process development engineer</li></ul> Responsibilities:&nbsp; <ul><li>Analyze new technology and manufacturing processes.</li><li>Plan and assess the feasibility of new and running projects.</li><li>Ensure good interfaces between Production, Production Planning, Engineering, QC and other functions.</li><li>Plan, design, and monitor manufacturing improvement processes using work study techniques. Ensure Day to day accountability &amp; support Production team to achieve targets by process improvements, training, FAI etc.&nbsp;&nbsp;</li><li>Develop new process and create all process documents like PFC, PFMEA, Control plan and SOP by understanding the depth of product requirements.&nbsp;</li><li>Vendor management, Programming, Installation, and commissioning of new Equipment’s and co-ordinate with CFT for complete process validation.&nbsp;</li><li>NPI/NPD projects execution, development and creation of all required FAI documentations and approvals.&nbsp;</li></ul> Requirements: <ul><li>BE/ B.Tech (Industrial/Electronics, Mechanical)</li><li>Minimum 7 to 9 years of industrial experience with 4 years of project management experience.</li><li>Experience in quality &amp; productivity improvement projects Experience in New product development from scratch i.e. customer order to Production handover</li></ul>

Responsibilities: Operate &amp; Maintenance <ul><li>Leads safe, compliant operation and maintenance of electrical infrastructure, establishes and controls MOS/SOP with strong change management, maintains accurate technical documentation, partners with Engineering, Operations, and EHS on regulatory compliance, drives risk and safety programs (FMEA, LOTO, arc flash, permits), and ensures full standards compliance and audit readiness.</li></ul> Reliability &amp; Risk Management <ul><li>Drives root cause analysis for electrical disturbances, leads predictive and preventive maintenance programs, and strengthens system reliability to minimize unplanned downtime.</li></ul> Capacity Planning &amp; Tool Install <ul><li>Plans and manages electrical load models across fab and facilities operations, ensures proper feeder loading, redundancy, and diversity, and reviews/approves designs while overseeing safe energization and commissioning.</li></ul> Projects &amp; Commissioning <ul><li>Define acceptance criteria, test protocols, and witness critical tests.</li><li>Manage vendor performance and ensure documentation close out (O&amp;Ms, as builts).</li></ul> Power Quality &amp; Energy Performance <ul><li>Monitor PQ and deploy mitigations (filters, SEMI F47 ride through, UPS tuning).</li><li>Drive energy efficiency projects (e.g., transformer loading optimization, UPS efficiency, busway losses, smart metering analytics).</li></ul> Requirements: <ul><li>At least a Bachelor’s degree in Electrical Engineering or equivalent.</li><li>Minimum 6 years of related work experience in Electrical Engineering within wafer fab/semiconductor</li><li>Experience in high volume manufacturing of electronics components in an MNC or semi-conductor industry.</li><li>Direct working experience in wafer fab facilities will be added advantage.</li><li>Possess strong technical competencies in his field of study.</li><li>Able to work under pressure and with strong commitment at work.</li><li>Experience with software applications such as MS Power Point, Excel and Word.</li></ul>

Responsibilities: <ul><li>Perform routine environmental monitoring (viable and non-viable) in classified cleanroom areas (Grade A/B/C/D), including surface and personnel monitoring. Manufacturing is performed inside isolators with surrounding grade C environment.</li><li>Collect and test samples from water systems (e.g., purified water, WFI), compressed gases, and other utilities per GMP and site procedures.</li><li>Support aseptic process simulations (media fills), including preparation, execution, and recovery/interpretation of microbiological data.</li><li>Perform microbiological tests such as bioburden, endotoxin (LAL), and sterility testing for raw materials, in-process samples, and finished products.</li><li>Prepare microbiological media, perform growth promotion testing, and maintain inventory of reagents and supplies.</li><li>Maintain laboratory notebooks, logs, and electronic systems in a compliant and organized manner, ensuring adherence to data integrity standards.</li><li>Support qualification and validation activities including cleanroom and utility qualifications, method validations, and EM qualification mapping.</li><li>Assist in investigations related to microbial excursions or deviations and contribute to the development and implementation of CAPAs.</li><li>Support microbiology lab startup activities including equipment qualification, SOP development, and execution of technical transfer protocols.</li><li>Follow all safety, quality, and regulatory policies, and maintain compliance with cGMP, USP, EU Annex 1, and other applicable guidelines.</li></ul> Requirements: Qualifications/Experience: <ul><li>Associate’s or bachelor’s degree in microbiology, Biology, Life Sciences, or a related field.</li><li>1–3 years of microbiology laboratory experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.</li><li>Experience working in sterile environments or supporting aseptic processes preferred.</li><li>Familiarity with environmental monitoring equipment (e.g., particle counters, air samplers), microbiological techniques, and lab instrumentation.</li><li>Knowledge of cGMPs, data integrity principles, and microbiological standards (USP &lt;61&gt;, &lt;62&gt;, &lt;71&gt;, &lt;85&gt;, &lt;1116&gt;).</li></ul> Skills/Competencies: <ul><li>Strong attention to detail and commitment to data accuracy and integrity.</li><li>Ability to work independently while collaborating effectively within a team</li><li>Good time management and organizational skills to support multiple tasks and priorities.</li><li>Proficient in the use of Microsoft Office and basic laboratory software systems.</li><li>Willingness to work flexible shifts or weekends to support aseptic operations and testing schedules, as needed.</li><li>A proactive and patient-focused mindset with a strong sense of ownership and compliance.</li></ul>

Responsibilities : <ul><li>Facilitate the global Sales and Operating Planning (S&amp;OP) process by conducting a reliable and efficient monthly demand review for the designated territory and product lines.</li><li>Collaborate with the sales team and product management to create an accurate and comprehensive consensus forecast, which includes organizing formal monthly demand review meetings.</li><li>Partner with the sales organization, global product management team, and Finance team in the quarterly commit sales forecasting process and annual sales budgeting process.</li><li>Deliver monthly product mix forecasts to the operations and supply chain teams, highlighting potential opportunities for growth as well as any associated risks</li><li>Track the demand plan against actual results on a monthly basis, assessing forecast accuracy and providing detailed insights to operations. Hold key contributors - such as product management, sales, and operations - accountable for their performance.</li><li>Drive continuous improvement on processes and methodologies for collecting information and predicting demand.</li><li>Consistent attendance, understanding of, and compliance with company policies, rules, and regulations.</li></ul> Requirements: <ul><li>Bachelor’s degree, or its equivalent, in a related field, such as finance, marketing, business administration, supply chain, operations management, or industrial engineering required. APICS or other certification is preferred.&nbsp;</li><li>Excellent analytical and advanced computer skills (such as Excel), with the ability to mine data and derive critical and salient information from diverse inputs.&nbsp;</li><li>Experience with analytical systems and tools (IBP/SAP/Data Warehouse, etc.) preferred.</li><li>Quick learner, capable of adapting to new systems and developing and continuously improving processes.</li><li>Excellent communication skills (clear, concise oral and written presentations), interpersonal skills, effective negotiation and influencing skills, capable of being unbiased and fair in achieving compromise solutions and consensus positions.&nbsp;</li><li>3-5 years experience in S&amp;OP, demand planning, supply chain, material planning, or capacity planning.&nbsp;</li><li>Fluent in Putonghua and English.</li><li>Project management and problem-solving skills.</li><li>Ability to work independently in an international environment and willing to travel periodically (short periods) including abroad if needed.</li></ul>

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15 sop Jobs found

Scientist I, Quality Control LTS

Operator III, Packaging - 2nd Shift

Process Engineering Manager

Project Manufacturing Leader

Business Strategy Analyst

Chemist Data Reviewer

Supervisor-Manufacturing Process Development Engineer

Facility Engineering - Electrical / Mechanical

Microbiology Technician

Demand Analyst

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15 sop Jobs found

Scientist I, Quality Control LTS

Operator III, Packaging - 2nd Shift

Process Engineering Manager

Project Manufacturing Leader

Business Strategy Analyst

Chemist Data Reviewer

Supervisor-Manufacturing Process Development Engineer

Facility Engineering - Electrical / Mechanical

Microbiology Technician

Demand Analyst

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.