QC Chemist

Senior Microbiology Technician

Microbiology Technician

Supervisor – Quality & Reliability Engineering

QC Laboratory Manager

R&D Product Development Engineer - Bengaluru

Staff Simulation Engineer - CFD

Supervisor – Quality and Reliability Engineer

Manager II – Quality & Reliability Engineering

MPDE CA Process Design Engineer(Senior Engineer)

Role Description: <ul><li>The QC Chemist will be a critical member of the laboratory team responsible for performing analytical testing to ensure the quality, safety, and compliance of sterile injectable IV bag products at a newly established greenfield pharmaceutical manufacturing facility.</li><li>This role will support the development, validation, and execution of analytical methods, ensure timely release of raw materials, in-process samples, and finished products, and maintain strict adherence to cGMP, FDA, and global regulatory standards.</li><li>The QC Chemist will play a key role in establishing laboratory operations during the startup phase and sustaining high standards of laboratory excellence throughout routine commercial production.</li></ul> Responsibilities: <ul><li>Perform analytical testing of raw materials, in-process samples, stability samples, and finished products using validated methods (e.g., HPLC, GC, UV-Vis, FTIR, TOC, etc.).</li><li>Develop and validate new analytical methods as required to support product development, regulatory submissions, and process optimization.</li><li>Ensure compliance with cGMP, FDA, USP, and other regulatory standards in all laboratory activities, documentation, and data integrity.</li><li>Prepare and review laboratory documentation including test protocols, reports, COAs, deviations, OOS investigations, and change control documentation.</li><li>Maintain laboratory instruments, perform routine calibrations, troubleshooting, and coordinate with vendors for preventive maintenance and repairs.</li><li>Support laboratory readiness for regulatory inspections, audits, and customer visits by maintaining audit-ready documentation and laboratory practices.</li><li>Assist in the preparation and execution of laboratory investigations, CAPA implementation, and root cause analysis for any analytical deviations.</li><li>Collaborate with cross-functional teams including Manufacturing, Quality Assurance, Validation, and Regulatory Affairs to ensure seamless batch release and product compliance.</li><li>Participate in training programs to ensure technical competency and adherence to evolving regulatory requirements.</li><li>Contribute to continuous improvement initiatives focused on laboratory efficiency, data integrity, and compliance robustness.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s or master’s degree in chemistry, Pharmaceutical Sciences, or related field.</li><li>3+ years of experience in pharmaceutical QC laboratory, preferably in sterile injectable manufacturing.</li><li>Strong hands-on experience with analytical instrumentation (HPLC, GC, UV, FTIR, etc.) and GMP-compliant laboratory operations.</li><li>Knowledge of FDA cGMP regulations, USP standards, ICH guidelines, and data integrity expectations.</li><li>Experience supporting laboratory investigations and regulatory inspections.</li></ul> Skills/Competencies: <ul><li>Strong analytical and problem-solving skills.</li><li>High attention to detail and accuracy in laboratory work.</li><li>Good understanding of data integrity and documentation practices.</li><li>Ability to work both independently and as part of a team in a dynamic startup environment.</li><li>Excellent organizational, time management, and communication skills.</li><li>Ability to adapt to evolving processes and regulatory requirements in a greenfield manufacturing setting.</li></ul>

Responsibilities: <ul><li>Perform and oversee complex microbiological activities, including environmental monitoring (viable and non-viable), utility sampling (e.g., water, compressed gases), and aseptic process support in areas utilizing isolator technology.</li><li>Conduct and review microbiological testing for bioburden, endotoxin (LAL), sterility, and microbial identification on raw materials, in-process samples, and final products.</li><li>Support and lead aspects of aseptic process simulations (media fills) including planning, execution, incubation, and interpretation of results within isolator systems.</li><li>Assist in the startup and qualification of the microbiology laboratory including equipment qualification, SOP development, method verification/validation, and environmental monitoring qualification.</li><li>Contribute to investigations, non-conformances, and microbiological excursions by providing subject matter expertise and supporting root cause analysis and CAPA implementation.</li><li>Ensure accurate and timely documentation of laboratory data in compliance with data integrity principles and cGMP guidelines.</li><li>Mentor and provide technical guidance to junior microbiology staff, fostering a culture of scientific excellence, compliance, and continuous learning.</li><li>Maintain laboratory readiness for internal and external audits by following and enforcing good laboratory practices and cGMP expectations.</li><li>Participate in ongoing improvements to laboratory procedures, contamination control strategies, and sterility assurance programs.</li><li>Interface cross-functionally with Quality Assurance, Manufacturing, Validation, and Engineering to support cleanroom and equipment qualifications, isolator decontamination cycles, and site expansion activities.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in microbiology, Biology, Life Sciences, or a related field.</li><li>Minimum of 3-5 years of microbiology laboratory experience in a cGMP pharmaceutical or biotechnology manufacturing environment.</li><li>Experience with isolator-based sterile manufacturing processes and aseptic support activities is strongly preferred.</li><li>Working knowledge of cGMPs, FDA and EU Annex 1 requirements, and microbiological standards (USP &lt;61&gt;, &lt;62&gt;, &lt;71&gt;, &lt;85&gt;, &lt;1116&gt;).</li><li>Experience supporting laboratory equipment startup, qualification, and routine maintenance preferred.</li><li>Prior experience with high potent APIs and/or controlled substances is desirable.</li></ul> Skills/Competencies: <ul><li>Advanced technical skills in environmental monitoring, microbial testing, and aseptic processing support.</li><li>Strong documentation and data integrity skills with a meticulous attention to detail.</li><li>Demonstrated ability to troubleshoot microbiological and laboratory equipment issues.</li><li>Effective time management and prioritization skills in a fast-paced environment.</li><li>Strong communication skills with the ability to train and mentor junior staff.</li><li>Proactive, collaborative, and compliance-oriented mindset.</li><li>Comfortable working in cleanroom environments and adhering to gowning and contamination control protocols.</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>Collaborate with engineering, production, and planning teams to continuously improve product quality across the manufacturing process.</li><li>Supervise and manage the incoming and final inspection areas.</li><li>Drive improvement initiatives within incoming, in-process, and final inspection operations.</li><li>Prioritize inspection activities to ensure timely completion of production materials, engineering validations, and gage R&amp;Rs.</li><li>Identify and execute containment actions for nonconforming materials found during in-process or final inspections.</li><li>Work with cross-functional teams to investigate nonconforming products using root cause analysis tools (Ishikawa, 5-Whys, Is-Is Not, etc.) and implement corrective and preventive actions.</li><li>Communicate with customers regarding product-related complaints and facilitate evaluation and return of materials as needed.</li><li>Investigate product quality issues related to customer returns (e.g., nonconforming material reports, corrective actions).</li><li>Create and update operations procedures and documentation used within production.</li><li>Ensure compliance with quality assurance policies and procedures to meet or exceed customer expectations.</li><li>Implement continuous improvement initiatives to reduce defects, improve efficiency, and enhance product quality.</li><li>Conduct manufacturing and quality system audits to ensure compliance with ISO 13485.</li><li>Support operational projects such as Kaizen, data analysis, and problem-solving initiatives.</li></ul> Requirements: Qualifications/Background: <ul><li>Bachelor’s degree in Quality, Science, or Engineering preferred (High School Diploma with equivalent experience will be considered).</li><li>Prior experience as a Quality Engineer in a manufacturing environment.</li><li>5+ years of industry experience in a medical device manufacturing or pharmaceutical environment.</li><li>Supervisory or management experience preferred.</li><li>Working knowledge of FDA, ISO, and MDD quality systems applicable to medical device companies.</li><li>Excellent written and verbal communication skills.</li></ul>

Responsibilities: <ul><li>Establish and lead the QC laboratory, including analytical and microbiological functions, supporting sterile injectable IV bag production.</li><li>Oversee all testing activities: raw material, in-process, finished product, and stability testing, in compliance with applicable cGMP and regulatory requirements.</li><li>Support and manage startup, qualification, calibration, and maintenance of all QC lab equipment and systems to ensure operational readiness and regulatory compliance.</li><li>Develop and enforce strong data integrity practices, including procedures, training, and routine monitoring of laboratory systems and documentation.</li><li>Build and maintain a scientifically sound, compliant laboratory environment capable of supporting high-potent APIs and controlled substances.</li><li>Hire, train, and mentor laboratory personnel to ensure technical capability and compliance with laboratory and safety procedures.</li><li>Implement and maintain robust systems for documentation (SOPs, protocols, specifications), investigations (OOS, deviations), and CAPA management.</li><li>Lead and support analytical method transfers, validations, and technical investigations in collaboration with cross-functional teams.</li><li>Oversee microbiology operations, including environmental monitoring, utility sampling, sterility testing, and microbiological release activities.</li><li>Ensure inspection readiness and represent QC in audits, PAIs, and regulatory inspections.</li><li>Collaborate cross-functionally with QA, Validation, Engineering, Manufacturing, and Regulatory to ensure alignment and compliance across the site.</li><li>Ensure adherence to safety protocols, especially in handling high-potent materials and controlled substances.</li><li>Establish laboratory KPIs and drive continuous improvement in performance, compliance, and operational efficiency.</li></ul> Requrements: Qualifications / Experience: <ul><li>Bachelor’s or Master’s degree in Chemistry, Microbiology, or related scientific discipline.</li><li>8–12 years of pharmaceutical QC laboratory experience, including 3–5 years in a leadership role.</li><li>Experience with sterile injectable manufacturing, high-potent APIs, and controlled substances is required.</li><li>Deep knowledge of cGMP, FDA, ICH, USP, and applicable global regulatory standards.</li><li>Experience with startup or greenfield sites and laboratory buildouts preferred.</li><li>Demonstrated experience with method transfer, validation, and technical problem-solving.</li><li>Experience establishing equipment lifecycle programs, including qualification and maintenance.</li></ul> Skills / Competencies: <ul><li>Strong leadership with ability to build and develop high-performing lab teams.</li><li>Excellent technical knowledge in analytical and microbiological testing.</li><li>Deep understanding of data integrity principles and enforcement of best practices.</li><li>Proficiency in laboratory systems (LIMS, CDS, ELN) and equipment qualification.</li><li>Ability to manage complex lab operations in a startup environment.</li><li>Strong project management, documentation, and communication skills.</li><li>Commitment to patient safety, quality, and regulatory compliance.</li></ul>

Role Description:&nbsp;<ul><li>Design &amp; Development of automotive connector system.</li></ul> Responsibilities: <ul><li>Responsible for mechanical design of Connectors based on customer requirement for TS.</li><li>Responsible to carry out detailed mechanical design work including 3D modelling, Proposal /detail drawings for costing / production, initiating simulation and prepare design verification / product validation plan per requirement.</li><li>Responsible for choosing standard parts, features, material as per internal guidelines which would meet the internal / customer target process and cost.</li><li>Responsible for preparing and presenting design reviews per manufacturability, update design per suggestion and keep record.</li><li>Responsible for carrying out design change requests in a timely manner / own the product responsibility&nbsp;</li></ul> Requirements: <ul><li>B.E/B. Tech in Mechanical Engineering (equivalent) / Diploma with Post graduation&nbsp;</li><li>Knowledge about various phases of product realization / product development.</li><li>Knowledge of state-of-the-art design tools such as Creo / CAD tools,</li><li>Basic knowledge in manufacturing process (Machining, Molding, Stamping, Plating, etc.,)</li><li>Following are added advantage - Geometric Dimension &amp; Tolerancing (GD&amp;T), GPS, Electrical &amp; Electronic Components design and Development.</li><li>1-4 years of experience in Concept Design and Development of products preferably in plastic and stamped parts.</li><li>Good knowledge in Creo software / CAD tools, PDM windchill / Similar,</li><li>Basic knowledge about Tolerance stack-up and GD&amp;T / GPS</li><li>Basic knowledge on Plastics &amp; Sheet Metal components will be added advantage.</li><li>Good Conceptual, problem solving and Analytical Skills.</li><li>Ability to communicate effectively and accurately across multi-cultural groups.</li><li>Excellent Communication and Presentation skills.</li></ul>

Role Description: <ul><li>Executes complex simulations in CFD and Thermal to optimize design and manufacturing.</li><li>Develops complex Multiphysics simulation methods that meets design requirements in thermal management of Electronic Systems, especially in high-speed transceivers, connectors, and their assemblies.</li></ul> Responsibilities: <ul><li>Leading the development and implementation of complex Thermal simulation models to optimize manufacturing, designs or processes.</li><li>Perform calculation &amp; simulation on temperature distribution over system.</li><li>Conducted thermo-mechanical and structural simulations to support design optimization, material selection, and validation from concept to production.</li><li>Proficient in simplifying complex CAD geometries for efficient structural and thermal simulation analyses</li><li>In-depth knowledge of mechanical design, conductive, convective, &amp; radiation heat transfer, and fluid flow mechanics.</li><li>Collaborate with designer, manufacturing, and testing teams to correlate CFD &amp; Thermal Simulation results with physical testing</li><li>Experience with DOE (Design of Experiments) and optimization techniques.</li></ul> Requirements: <ul><li>BE/ B.Tech (Mechanical)</li><li>M Tech (Mechanical) (preferred)/ PHD</li><li>Knowledge of products, design processes and methodology.</li><li>Proficiency in state-of-the-art&nbsp;</li><li>Proficiency in use of MS Office tools.</li><li>Knowledge of associated manufacturing processes (molding, stamping, plating, crimping &amp; assy).</li><li>Knowledge about the Soldering, crimping &amp; welding technologies.</li><li>Knowledge on technical paper publications &amp; applying for patents.</li><li>8- 12 years of industry experience.</li><li>Expertise in Ansys Workbench.</li><li>Experience on connector products (Plastic and Sheet Metal parts).</li><li>Knowledge on material science (Metals, Resins &amp; hyper elastic material) and implement for simulation.</li><li>Correlation of Test and simulation data / results.</li><li>Expertise on CAE tools, Optimization techniques, and testing methods.</li><li>Implementing of LEAN / 6 Sigma / Kaizen techniques to live projects.</li></ul>

Responsibilities: <ul><li>Manage the day-to-day activities of the team in a safe environment and be responsible for Health and Safety goals.</li><li>Deliver on all KPIs that help the business achieve its objectives.</li><li>Lead and drive QA initiatives within the functional area.</li><li>Provide quality input and support to Manufacturing, Engineering, Prototype, and Commercial functions.</li><li>Lead, coordinate, and maintain risk assessment documentation (e.g., FMEAs).</li><li>Investigate the root cause of quality issues and implement timely and effective corrective actions to prevent recurrence for both customer and internal issues.</li><li>Strategically lead new product introduction (NPI) and contract reviews from a QA perspective.</li><li>Prepare and update Operations procedures and associated documentation.</li><li>Overall responsibility for functional area GMP standards and compliance, including promoting quality awareness.</li><li>Establish inspection standards, sampling plans, and test methods.</li><li>Report quality metrics to management.</li><li>Develop strong links with customer organizations and other project stakeholders.</li><li>Review validation documentation for the functional area.</li><li>Perform and support internal and external audits to ISO and FDA requirements.</li><li>Actively contribute to the continuous improvement of the Quality Management System.</li><li>Supervise and provide direction to quality personnel.</li><li>Perform other tasks as directed by the Operations Quality Manager in line with company goals.</li></ul> Requirements: <ul><li>Level 8 degree in Science, Engineering, or related field.</li><li>Minimum of 5 years industry experience in a medical device manufacturing environment.</li><li>People management experience.</li></ul> Key Requirements <ul><li>Clear understanding of medical device quality systems and requirements, including measurement techniques.</li><li>Experience managing and leading a team.</li><li>Strong CAPA experience.</li><li>Strong root cause analysis and problem-solving skills.</li><li>Knowledge of FDA and ISO Quality systems for medical device companies is desirable.</li><li>Experience in new product introduction (NPI) and manufacturing process transfers is desirable.</li><li>Demonstrated excellent organizational skills and ability to work independently.</li><li>Excellent written and verbal communication skills.</li></ul>

Responsibilities: <ul><li>Lead development and execution of standardized DfRE and RV methodologies across Converged Products.</li><li>Champion a Design for Six Sigma (DFSS) culture, mentoring and training product design teams.</li><li>Oversee product validation, including HALT/HAST testing, Test-to-Failure (TTF) methodologies, and DOE approaches.</li><li>Collaborate with Product Development Engineering (PDE), Manufacturing Process Development Engineering (MPDE), Field Application Engineering (FAE), and Advanced Quality Engineering (AQE) teams to integrate reliability considerations throughout the product lifecycle.</li><li>Develop comprehensive test and validation plans aligned with our client LeanPD stage-gate approach.</li><li>Drive early concept testing, failure mode identification, and iterative product design improvements.</li><li>Support failure analysis (F/A), Root Cause and Corrective Action (RCCA), and competitive benchmarking activities.</li><li>Partner with Global R&amp;T COE to develop custom test equipment, test systems, and software for unique testing requirements.</li><li>Manage and coach a high-performing team, ensuring clear accountability, skill development, and work-life balance.</li></ul> Requirements: <ul><li>Bachelor’s or Master’s degree in Electrical Engineering, Electronics, or Mechatronics.</li><li>10+ years of experience in all aspects of reliability engineering for electronic or mechatronic products (reliability estimation, calculation, and risk identification).</li><li>Extensive experience with test equipment, test systems, labs, HALT/HAST testing, validation plans, and custom test systems.</li><li>Proven experience working with global, cross-functional engineering teams in multi-site organizations.</li><li>Strong analytical, critical thinking, and problem-solving skills.</li><li>Knowledge of FIT estimation methodology, Weibull/Chi-Square statistical analysis, FMEDA, FTA, and Bayes theorem applications.</li><li>Reliability engineering training from ASQ, TUV, Reliasoft, or equivalent.</li><li>Excellent written and verbal communication skills in English.</li><li>Willingness to travel up to ~20%.</li></ul>

Responsibilities: Process Solution Development: <ul><li>Design or optimize production process routes based on product design drawings (e.g., mechanical structures, electrical schematics), including raw material selection, process planning (e.g., cutting, wire pre-treatment, welding, forming, assembly, testing), equipment selection and parameter setting, and DOE development to ensure mass and stable production.</li><li>For new products (e.g., mechanical parts, electronic components), organize DFM reviews within the MPDE department, provide optimization suggestions from a manufacturability perspective, develop trial production process plans, participate in trial production, and resolve process issues (e.g., dimensional deviations, assembly difficulties, inefficiencies).</li></ul> Process Documentation: <ul><li>Prepare standardized process documents, such as SOPs, process flowcharts, PFMEA, and inspection standards, to clarify operational specifications and quality control points for each process, ensuring unified execution by production personnel.</li></ul> Production Efficiency and Quality Optimization: <ul><li>Analyze existing production processes, use lean production tools (e.g., 5S, value stream analysis) or technical improvements (e.g., introduction of automated equipment, process consolidation) to reduce production costs, shorten cycle times, and enhance capacity.</li><li>Collaborate with the quality department to investigate the causes of quality anomalies (e.g., excessive defect rates) from a process perspective (e.g., insufficient equipment precision, unreasonable process parameters), develop improvement measures, and validate their effectiveness through DOE.</li></ul> Cross-Department Collaboration: <ul><li>Work with R&amp;D departments, participate in product design reviews, provide suggestions from a process feasibility perspective (e.g., simplifying structures to reduce assembly difficulty), and promote Design for Manufacturability (DFM).</li><li>Communicate with supply chain departments to confirm the process compatibility of raw materials and assist in resolving process-related issues with purchased materials. Cooperate with production departments to train operators on new processes and equipment, ensuring successful implementation.</li><li>Collaborate closely with automation teams, participate in automation solution reviews, and develop validation methods.</li></ul> Technological Innovation and Cost Reduction: <ul><li>Stay updated on industry advancements (e.g., 3D printing, smart inspection equipment, laser welding), evaluate their applicability to existing production, and drive process upgrades. Achieve cost reduction through process optimization and the use of alternative low-cost materials (without compromising quality).</li></ul> Requirements: Education and Major: <ul><li>Bachelor’s degree or higher in Mechanical Engineering, Materials Science and Engineering, Industrial Engineering, Electrical Automation, or related fields.</li></ul> Knowledge and Skills: <ul><li>Mastery of fundamental manufacturing process principles (e.g., machining, electronic assembly, heat treatment) and familiarity with production processes in at least one industry (e.g., automotive parts, electronic devices, machinery manufacturing).</li><li>Strong process analysis skills, ability to interpret drawings using CAD/SolidWorks, and perform data analysis with tools like Minitab (e.g., analyzing defect rate causes).</li><li>Knowledge of quality and efficiency improvement methods such as Lean Production and Six Sigma; prior experience in process optimization projects is preferred.</li></ul> Experience Requirements: <ul><li>Typically requires 5+ years of experience in process development or production technical support in relevant industries; familiarity with high-speed cable equipment and process requirements is preferred.</li></ul>

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29 validation Jobs found

QC Chemist

Senior Microbiology Technician

Microbiology Technician

Supervisor – Quality & Reliability Engineering

QC Laboratory Manager

R&D Product Development Engineer - Bengaluru

Staff Simulation Engineer - CFD

Supervisor – Quality and Reliability Engineer

Manager II – Quality & Reliability Engineering

MPDE CA Process Design Engineer(Senior Engineer)

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29 validation Jobs found

QC Chemist

Senior Microbiology Technician

Microbiology Technician

Supervisor – Quality & Reliability Engineering

QC Laboratory Manager

R&D Product Development Engineer - Bengaluru

Staff Simulation Engineer - CFD

Supervisor – Quality and Reliability Engineer

Manager II – Quality & Reliability Engineering

MPDE CA Process Design Engineer(Senior Engineer)

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

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