Senior - Data Engineer

Equipment Engr - Automation and PLC

Manufacturing Engineer II - CCD Support

Continuous Improvement Analyst II

Senior Manager Channel Sales

Senior Quality & Reliability Engineer

Finance Business Partner

Senior Project Management Engineer

QC Lab Sample Coordinator

QE Specialist

Responsibilities: <ul><li>Uses a set of tasks and techniques to work as a liaison among and elicit the needs of stakeholders to define and validate solutions that meet business needs, goals, or objectives.</li><li>Analyzes and synthesize information elicited from stakeholders, defines, and manages the plan to deliver requirements and documents, and manages requirements throughout the project life cycle.</li><li>Develop ETL (Extract, transform, load) process to help extract and manipulate data from multiple sources.</li><li>Reformulating or automating the existing data workflows to maximize their functioning and greater scalability.</li><li>Critically evaluate information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, and produce actionable business insights out of it.</li><li>Need to conduct complex data analysis and improve data quality and efficiency.</li><li>Develop models to create reporting infrastructure/dashboards for business process management and data mining.</li><li>Design Summary, Detail, and Dashboard reports and management summaries which present data findings in a professional, concise, and readable format appropriate for content and audience.</li><li>Solve ad-hoc requirements of Management related to data for critical decision making</li><li>Troubleshoot data inaccuracies, identify root causes, and take corrective action</li><li>Effectively communicate and translate quantity findings (Storytelling with data) inclusive of key insights and actionable recommendations to optimize performance</li><li>Optimize reports to ensure a responsive solution when visualizing vast amounts of data.</li></ul> Requirements: <ul><li>5+ years of data engineering experience in ETL design, development, optimization &amp; testing using, Alteryx, Data Bricks, Cloud AWS Services, Python, SQL scripts,</li><li>5+ years of hands-on experience in business intelligence and in configuring, designing, and building visualizations and dashboards using Tableau and other BI tools (Tableau Prep, Tableau Dashboard, Tableau Server, Business Objects, Power BI, etc.)</li><li>Excellent problem-solving, communication, and organizational skills.&nbsp;</li><li>Experience in performance tuning and optimization of ETL processes to enhance efficiency and minimize data processing time</li><li>Detail-oriented with excellent time management and organizational skills to meet a critical deadline</li><li>Self-motivated, ability to prioritize work and multi-task across many assignments in a fast-paced work environment</li><li>Collaborated with cross-functional teams to gather requirements, design data models, and implement scalable data architectures to support business analytics and reporting needs</li><li>Proven ability to work independently and with a team.</li><li>Ability to interpret technical or dashboard structure</li><li>Experience in business domains – supply chain, pricing, sales &amp; marketing, sales, finances</li></ul>

Overview: <ul><li>The Equipment Engr - Automation and PLC is responsible for ensuring the reliable performance of production equipment by developing, modifying, and troubleshooting PLC programs and CCD (vision) systems.&nbsp;</li><li>The role supports day-to-day plant operations through automation debugging, sequencing improvements, and real-time issue resolution to enhance productivity and OEE.&nbsp;</li><li>This position leads technical training for technicians and new team members, documents system updates, and contributes to continuous improvement initiatives, including deployment and ISO compliance.&nbsp;</li><li>The engineer serves as a key resource in maintaining stable, efficient, and high-quality automated manufacturing processes.</li></ul> Responsibilities: <ul><li>Trouble shooting, Modify or Create Machine PLC program to suit the need of the plant.</li><li>Responsibel for repair and maintenance of the CCD System of the production line.</li><li>PLC system of the automation debugging and improve the sequencing.</li><li>Suggest improvement of automation PLC program to improve productivity and OEE.</li><li>Train technician to resolve the issues encountered between the production.</li><li>CCD light adjustments to improve the performance.</li><li>Responsible to resolve all issues encounter during production run.&nbsp;</li><li>Support on resolving CCD issues encounter during production run and documenting.&nbsp;&nbsp;</li><li>Impart trainings and development for new joiners, Technical Trainees etc.</li><li>Review of deployment</li><li>Review ISO documents and update, Engage in ISO audits.</li></ul> Requirements:&nbsp; <ul><li>Bachelor in Major in Electrical/Electronics</li><li>Preferably Mechanical, Electrical/Electronics and Industrial Engineer,</li><li>5 years minimum experience in the automation assembly and Tooling Design &amp; Development</li></ul> Knowledgeable on this different type of Programming Languages: <ul><li>Ladder Logic</li><li>Function block diagrams</li><li>Structured text</li><li>Sequential flow charts</li><li>Instruction List</li></ul>

Overview: <ul><li>Design and developed electrical control system,testing and qualification introduce advanced electrical control technology with the objective of ensuring new assembly equipment meets schedule and requirements from customers and ECO within the direction of department manager and staff manufacturing engineer.&nbsp;</li><li>Manage and trouble shooting of CCD and cost saving within direction of policies.</li></ul> Responsibilities: <ul><li>Trouble shooting, Modify or Create Machine PLC program to suit the need of the plant.</li><li>Responsible for repair and maintenance of the CCD System of the production line.</li><li>PLC system of the automation debugging and improve the sequencing.</li><li>Suggest improvement of automation PLC program to improve productivity and OEE.</li><li>Train technician to resolve the issues encountered between the production.</li><li>CCD light adjustments to improve the performance.</li><li>Responsible to resolve all issues encounter during production run.&nbsp;</li><li>Support on resolving CCD issues encounter during production run and documenting.&nbsp;&nbsp;</li><li>Impart trainings and development for new joiners, Technical Trainees etc.</li><li>Review of deployment</li><li>Review ISO documents and update, Engage in ISO audits.</li></ul> Requirements:&nbsp; <ul><li>Bachelor in Major in Electrical/Electronics</li><li>5+ years’ experience and practitioner in the automation assembly and Tooling Design &amp; Development</li><li>Computer Knowledge, MS Office etc, SAP knowledge added advantage</li><li>Integrity, Accountability, innovation, Communication.&nbsp;</li><li>Strong background in PLC programming: capable of programming, debugging, editing, and creating new PLC logic.&nbsp;</li><li>Familiar with CCD (Charge-Coupled Device) cameras, especially those used in automated measurement systems (e.g., Autoline).&nbsp;</li><li>Experience with vision system programming tools such as Visco, Keyence, and Datalogic.&nbsp;</li><li>Solid programming skills required; CCD-specific knowledge can be trained.&nbsp;</li><li class="ql-align-justify">Willingness to work on Saturdays when needed</li></ul>

Overview:﻿ <ul><li>Working with the Lean implementation team to integrate Lean tools into operations as well as drive performance improvement.&nbsp;</li><li>Act as the local subject matter expert for the Lean tools and be responsible for all Lean activities at the local site.&nbsp;</li><li>Develop and conduct the Lean star level plan by driving and monitoring the projects of operation advantage, providing necessary technical support and facilitating cross-functional team to meet the metrics as planned.&nbsp;</li></ul> Responsibilities: <ul><li>Overall manage plant annual lean plan, identifying key improvement priorities to enhance site performance in the eyes of all stakeholders.</li><li>To implement system in plant and achieve Star level plant through improvement activity.</li><li>Conduct site level workshops and VSM transformation projects with focus on achieving operational excellence.&nbsp;</li><li>Systematic to manager plant cost activity, identify/improve/control the efficiency, material, labor and be all aspect of the cost viewing. </li><li>Being responsible fofr driving conversion productivity.&nbsp;</li><li>Key member of global lean committee, share/provide/lead global projects and activities.</li><li>Take role as internal process/cost consultants, to assistant plant manager solve management issues</li><li>Provide leadership on lean thinking, lean processing and lean production, continue to promote the culture of continuous improvement.</li><li>Lead / lean know-how transfer projects, to implement, optimize and solve specific problems in operation&nbsp;</li></ul> Requirements: <ul><li>B.S. Degree in engineering or technical field.</li><li>Minimum 8 years working experiences, 3 years working experiences as Continuous Improvement at least.&nbsp;</li><li>Professional experience with focus on production, logistics or industrial engineering is an advantage.</li><li>Previous experience in leading both of continuous improvement activities and value stream transformation projects.</li><li>Good flexibility and can work under pressure</li><li>Demonstrate the ability to lead change, a great team-work player.</li><li>Excellent communication and coaching skills, strong leadership skills.</li><li>Ability to think strategically and execute tactically, being result-oriented.</li><li>Project management skills.</li><li>Fluent in both spoken and written English and local language is essential.</li><li class="ql-align-justify">Lean Six Sigma Black Belt Certification is an advantage</li></ul>

Role Description:&nbsp;<ul><li>Senior Manager – Customer Service is responsible for continuing to drive transformational customer centric strategies geared around delivering extraordinary customer experiences and driving sales growth for the team, while continuing the transformation of our Customer Care organization to a revenue generation organization through consultative selling. </li><li>The Manager would be also responsible for delivering a level of service &amp; driving unsurpassed growth which builds strong customer relationships to make client the supplier of choice. </li><li>Support Solution Center strategic initiatives and drive operational excellence. Support and mentor fellow team Leaders to meet/exceed organizational goals.</li></ul>&nbsp;Responsibilities:&nbsp;<ul><li>Responsible &amp; Accountable to drive revenue and revenue growth.</li><li>Ensure that customer’s challenges are solved by providing excellent customer experience that exceeds customer expectations.</li><li>Implement processes and methods to eliminate barriers and inhibitors to success on a local level.</li><li>Understands market influencers and conditions.&nbsp;</li><li>Drive/influence our current/future product positioning to gain or re-gain market share.&nbsp;</li><li>Understands key components of a Competitive Landscape: customers’ needs and how you can address those needs; how you compare against your competitors in meeting those needs.&nbsp;</li><li>Drives brand awareness and positioning with our customers and distribution partners (Solutions and capabilities).</li><li>Think strategically and lead multiple teams.</li><li>Mentor and develop team Leaders and nurture an environment where they can excel in their current role.</li><li>Own and be accountable for achieving specific departmental objectives and in meeting both sales and Customer Experience goals of Solution Center India.</li><li>Lead and drive all Global Solution Center strategic initiatives in India.</li><li>Equip your team to develop, enhance and grow customer relationships through lead generation, building an opportunity pipeline, nurturing customers through their buying journey and driving customer loyalty.</li><li>Observe and coach your team in their work activities, providing immediate feedback through coaching discipline and following up to ensure appropriate actions are taken by the team</li><li>Recruit new talent and develop a strong talent bench that will embrace the vision and transform the organization.</li><li>Champion transformation initiatives and positively drive the change initiatives within the team.&nbsp;</li><li>Drive operational excellence and continuous improvement mind-set within your team.</li><li>Grow and nurture your team by providing inclusion and engagement opportunities, as well as developing them for their future careers.&nbsp;</li><li>Liaising effectively with various internal business partners like engineering, planning, and sales to resolve Customer inquiries and requests.</li></ul> Requirements:&nbsp; QUALIFICATIONS &amp; EXPERIENCE&nbsp;<ul><li>Bachelor’s degree in Engineering/Management/Science required, MBA preferred.</li><li>Overall 20+ years of professional experience in a multi-national Sales &amp; Business development role leading Sales operations and/or Customer support, with at least last 10 years of experience in Managerial position leading large teams with good proven track records driving sales, customer satisfaction and developing high performing teams.</li><li>Previous experience working in Corporate Sales and should have managed Channel sales, Distribution, customer support &amp; contact center.</li><li>Proven success record of change management efforts in pre &amp; Post Sales Process, customer Support &amp; Sales functions.</li><li>Proven experience of leading large and multi layered teams</li><li>Strong Skills to Drive Opportunity/leads through system like SFDC.</li><li>Excellent knowledge of management methods and techniques.</li><li>Demonstrated experience in working effectively and directly with all levels of the organization.</li><li>Industry specific experience is a plus.</li><li>Excellent communication skills.</li></ul>&nbsp;COMPETENCIES/SKILLS:&nbsp;<ul><li>Customer ‘centric’ and sales mind-set.</li><li>Business Acumen.</li><li>Consultative Selling experience &amp; skills.</li><li>Ability to lead team spread in different countries within your region.</li><li>Servant Leadership.</li><li>Result oriented.</li><li>Ability to maintain progress on multiple tasks, set priorities, and manage time effectively</li><li>Ability to adapt, be agile and drive change.</li><li>Strong communication (written and verbal), persuasion and interpersonal skills</li><li>Ability to establish strong business relationships with other Business units and cross functional departments.</li><li>Ability to influence without authority</li><li>Collaborative, ability to build strong relationships with cross-functional partners within a global and diverse organization.</li><li>Demonstrate proactive positive attitude and instill the same within the team.</li></ul>&nbsp;KEY PERFORMANCE MEASUREMENTS:&nbsp;<ul><li>Strategy, Execution and Talent (SET).</li><li>Employee Engagement.</li><li>Revenue &amp; New Customer Acquisition.</li><li>Customer Effort Score.</li><li>Efficiency/Productivity Improvement.</li></ul>&nbsp;MOTIVATIONAL/CULTURAL FIT&nbsp;<ul><li>Be a coach.</li><li>Building Effective teams.</li><li>Managing and Measuring Work.</li><li>Self-Motivated.</li><li>SET: Strategy, Execution, Talent (for managers).</li><li>Values: Integrity, Accountability, Inclusion, teamwork, Innovation.</li></ul>

Responsibilities: Quality System &amp; Compliance <ul><li>Develop and implement quality and reliability processes to support NPI.</li><li>Lead the development and scaling of the site Quality Management System (QMS).</li><li>Ensure QMS elements (management reviews, internal audits, supplier management) comply with global standards.</li><li>Act as Lead Auditor for internal audits and ensure compliance with ISO 13485 and FDA QSR.</li><li>Support external audits, including preparation, mock audits, and corrective actions.</li><li>Review and approve ECOs, DCOs, training matrices, and other NPI documentation.</li><li>Maintain updated quality policies and procedures aligned with evolving standards.</li></ul> NPI Planning &amp; Execution <ul><li>Represent Quality in customer meetings and business reviews.</li><li>Collaborate with cross-functional teams including engineering, manufacturing, PMO, and supply chain.</li><li>Support implementation of electronic quality systems for improved traceability and documentation.</li><li>Evaluate product development objectives to identify quality improvement opportunities.</li><li>Create, review, and maintain quality system documents specific to NPI.</li><li>Calculate and present NPI quality KPIs.</li></ul> Continuous Improvement &amp; Problem Solving <ul><li>Lead or support quality system improvement projects.</li><li>Use statistical and scientific methods to analyze data and drive improvements.</li><li>Provide expertise in CAPA, root cause analysis, and reliability engineering tools.</li><li>Facilitate cross-functional improvement teams focused on NPI processes.</li></ul> Training &amp; Leadership <ul><li>Conduct training in GDP, GMP, CAPA, and compliance topics.</li><li>Oversee CAPA investigations to ensure true root cause identification and effective corrective actions.</li><li>Supervise and mentor Quality Engineers supporting NPI initiatives.</li></ul> Requirements: Required Skills &amp; Competencies Core Competencies <ul><li>Strong technical learning ability</li><li>Excellent problem-solving and analytical thinking</li><li>High ethical standards and integrity</li><li>Action-oriented and self-driven</li></ul> Job-Specific Skills <ul><li>Knowledge of NCMRs, CARs, CAPA, customer complaints, RMA metrics, DPPM, and DLPM</li><li>Strong technical "hands-on" skills</li><li>Excellent communication and interpersonal abilities</li><li>Ability to manage multiple tasks in a fast-paced environment</li><li>Strong prioritization and organizational skills</li><li>Proficiency in Microsoft Office (Word, Excel, PowerPoint, Visio)</li><li>Advanced technical report writing skills</li><li>Strong understanding of ISO 13485 and FDA QSR</li><li>Bilingual English (Advanced) / Spanish preferred</li><li>Willingness to travel up to 20% (based in Costa Rica)</li></ul> Experience &amp; Education <ul><li>Experience: 5+ years of Quality leadership experience in a manufacturing environment, preferably in multinational settings and NPI roles.</li><li>Education: Bachelor’s degree in a scientific or engineering discipline.</li><li>Certifications: CQE/CSSBB certification preferred.</li></ul>

Responsibilities: <ul><li>The Finance Business Partner, Operations will be providing timely, relevant and accurate information and insightful analysis to facilitate decision-making of senior management.</li><li>Developing the capability to drive swift data extraction and visualization bringing visibility and transparency of key business metrics.</li><li>Focused on finding meaningful insights to support continued and sustainable profitable growth of the our client business.</li><li>Drive improvement in the conversion cost and site fixed overhead vs budget and historical periods.</li><li>Also, bringing actionable insights, identity focus areas and run simulations for site management to optimize the cost level, in line with forecasted business activity.</li><li>Need monthly tracking and action monitoring, working collaboratively with site teams across different functions, and create visibility with global manufacturing team on the improvement actions.</li><li>Drive digital transformation journey of finance function and be instrumental in increasing utilization of BI tools, especially Power BI.</li><li>To include developing the dashboards and power query models required to achieve efficiency in data extraction and visualization.</li><li>Understand diverse internal and external data source and its architecture.</li><li>Able to integrate various data source for seamless automation of business analysis resulting in optimization of core financial workflows, enhancing efficiencies.</li><li>Able to perform analysis using large complex dataset, enhance the reports to improve performance tracking against targets and trend identification.</li><li>Effective contribution in annual budgeting and monthly forecasting process, such as developing templates for end-to-end budget planning and forecasting process.</li><li>Build and foster strong cross-functional relationships across business constituencies and stakeholders specially group support functions like Supply Chain, Manufacturing Ops and Procurement. Help the company understand how the pieces fit together to drive performance and strengthen the team’s partnership and influencing skills in pursuit of growth.</li><li>Price, Mix and Volume Analysis for Margin Improvements</li><li>Proactive participation in various business improvement/ad hoc projects.</li><li>Manages the overall Financial Reporting and Analysis activities in the production and delivery of all standard reporting (including template and chart updates), ad hoc reporting, presentation materials; and non-pricing / profitability (costing) analysis for the business, in accordance with defined standards.</li></ul> Requirements: <ul><li>At least 8-10 years’ work experience in Finance with at least 6 years’ experience in FP&amp;A</li><li>Experience working in manufacturing environment is a must</li><li>Strong business acumen.</li><li>Strong financial, technical, and quantitative analytical skills</li><li>In-depth knowledge of accounting principles, practices and regulatory issues and their application to a wide variety of areas</li><li>Ability to take ownership of a task or process, and see it through from inception to completion</li></ul> Preferred Skills <ul><li>Proven track record of developing and implementing value-added financial analysis</li><li>Self-awareness and ability to handle tight deadlines and manage complex business challenges</li><li>Demonstrated experience in analyzing and synthesizing complex financial data into meaningful executive summary statements</li><li>Excellent verbal and written skills, analytical thinker / problem solver, interpersonal skills, attention to details</li><li>Advance Excel skill, MS office and data management, Power BI skill is added advantage</li></ul> Key Relationships with Internal and External Stakeholders <ul><li>Operational Leadership</li><li>Site Finance Controllers</li><li>Group Finance Team</li><li>Site GMs and Operation team</li></ul> Additional Notes <ul><li>Sound financial knowledge with Chartered Accountant background</li></ul>

Responsibilities: Project Timeline: <ul><li>Identify and align projects goals and scope with PJM and PM, and breakdown tasks of tooling/process developments and qualification</li><li>Make/align tooling development and qualification timeline, assign tasks to Ops team include tooling development, materials purchase</li><li>Track and manage core team to execute project progress based on committed project schedule</li></ul> Project Cost: <ul><li>Lead Ops to simulate sample cost and production cost to achieve project landing zone target, lead Ops to optimize launch cost to the best</li><li>Budget and control scrap cost though leverage design and manufacturing process to meet project target during NPI phase</li></ul> Project Execution: <ul><li>Guide capacity planning, materials sourcing and manpower to support all builds in the plant.</li><li>Oversee the progression of tooling/process development, identify bottleneck and issues, organize Ops team to improve those bottleneck and issues.</li><li>Oversee risks assessment in project execution, stay interlock with PJM to make multigation plan and conduct the planned activities in Ops.</li><li>Finalize the Safe Launch plan for the appropriate mix of product, tool capability and demand with the approval of the PjM, Quality, MDPE, and PjE. a. Lead Safe Launch team meetings to assure successful HVM startup and manufacturing process qualification for attainment of required metrics for successful G5 handoff.</li><li>Align the budget with Ops team with the tooling list provided by MPDE-A, control total capital spending against CER.</li><li>Lead and coordinate line setup to conduct LVM sample builds and coordinate HVM tool builds.</li><li>Lead Ops to make ramp up plan, include materials, operations and tool capacity ramp up, ensure manufacture team take over production control smoothly after G5.</li></ul> Product Sustaining: <ul><li>Product migration, as a receiving or sending leader to execute product move in or move out, including project timeline, investment, cost control, machine/material/manpower preparation, safety stock, safe launch, etc.</li><li>Lead product capacity analysis and expand it through re-investment per estimation.</li></ul> Requirements: <ul><li>Bachelor degree, engineering background is better</li><li>PMP certification preferred</li><li>At least 5 years related working experience in project management, 1~2 years experience in connector/cable/cable assembly is better</li></ul>

Responsibilities: Sample Management <ul><li>Performs QC sample/reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC sample reconciliation and disposal.</li><li>Tracks inventory of product samples, stability samples, and test materials in the lab.</li><li>Uses laboratory software for sample, reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with samples.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Send samples for outside testing. Submit samples to the appropriate labs for testing.</li><li>Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.</li><li>Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.</li><li>Uses the purchasing system to procure laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the submission of samples.</li><li>Maintain a safe work environment by following standards and procedures and complying with legal regulations.</li></ul> Lab Equipment <ul><li>Maintains, operates equipment and instruments supporting sample processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.</li><li>Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li></ul> Investigations&nbsp; <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any sample and reference standard documentation issues to the QC Lab Manager.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Assists, as and when needed, scientists working in the laboratory.</li><li>May assist in drafting, editing, and reviewing SOPs.</li></ul> Training <ul><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of laboratory staff.</li></ul> Compliance&nbsp; <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendia requirements within pharmaceutical manufacturing setting.</li><li>Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</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>College graduate, preferably in a Science related field.</li><li>Laboratory experience related to sample management preferred.</li></ul> Knowledge <ul><li>Basic knowledge of sample management in a laboratory environment.</li><li>Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Proficiency with computer savvy.</li></ul> Skills &amp; Abilities <ul><li>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>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 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.</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>

Responsibilities: <ul><li>Provide real-time QA oversight on the production floor, in warehouse areas, and during qualification activities.</li><li>Perform batch record and logbook review, ensuring accuracy, completeness, and compliance with GDP standards.</li><li>Execute and document line clearance and room readiness inspections prior to manufacturing activities.</li><li>Review qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated. 6.	Initiate, investigate, and support closure of deviations, non-conformances, and CAPAs related to manufacturing and qualification activities.</li><li>Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities.</li><li>Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.</li><li>Review and approve site procedures to ensure clarity and compliance with cGMP standards.</li><li>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Participate in internal walkthroughs, audit preparations, and readiness activities for regulatory inspections.</li><li>Support the implementation of continuous improvement initiatives and site quality metrics.</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)</li><li>2–5 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment</li><li>Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity</li><li>Experience supporting commissioning and qualification activities is strongly preferred</li><li>Familiarity with GDP, batch record review, and deviation documentation processes</li></ul> Skills/Competencies <ul><li>Strong attention to detail and commitment to compliance</li><li>Solid written and verbal communication skills</li><li>Ability to work collaboratively across departments in a fast-paced environment</li><li>Comfortable supporting shop-floor activities and cross-functional execution teams</li><li>Proficient in using quality systems and document management tools</li><li>Flexible and adaptable to changing priorities and evolving project timelines</li><li>Commitment to data integrity, continuous improvement, and patient safety</li></ul>

Skills

Industry

Location

Jobtitle

187 senior test engineer power electronics Jobs found

Senior - Data Engineer

Equipment Engr - Automation and PLC

Manufacturing Engineer II - CCD Support

Continuous Improvement Analyst II

Senior Manager Channel Sales

Senior Quality & Reliability Engineer

Finance Business Partner

Senior Project Management Engineer

QC Lab Sample Coordinator

QE Specialist

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

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

Skills

Industry

Location

Jobtitle

187 senior test engineer power electronics Jobs found

Senior - Data Engineer

Equipment Engr - Automation and PLC

Manufacturing Engineer II - CCD Support

Continuous Improvement Analyst II

Senior Manager Channel Sales

Senior Quality & Reliability Engineer

Finance Business Partner

Senior Project Management Engineer

QC Lab Sample Coordinator

QE Specialist

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

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

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