Research Associate – II Nitrosamines

Manager – ADL GMP

Manager – R&D F&D Emulsions

Manufacturing Engineer

Facility Engineer

Document Control Lead

Process Equipment Engineer

Software Development Engineer in Test

Wire/Cable Senior R&D/Product Development Engineer

Manufacturing & Process Development Engineer II (Wire & Cable)

Job Overview: <ul><li>The Research Associate – II – Nitrosamines is responsible for conducting analytical research, method development, and risk assessment activities focused on nitrosamine impurities in pharmaceutical products.&nbsp;</li><li>The role supports regulatory compliance, safety assessment, and mitigation strategies in line with global regulatory requirements (such as those from the FDA, EMA, WHO, and ICH M7). This position requires a strong understanding of organic chemistry, analytical instrumentation, and impurity profiling.</li></ul> Responsibilities: <ul><li>Development, validation, and transfer of LC/MS methods for quantitative determination of Nitrosamine impurities (Small Molecules and NDSRIs) at ppm to sub-ppb levels</li><li>Design and execution of experiments to identify root causes of Nitrosamine formation and develop mitigation strategies</li><li>Perform chemical extractions of container closure systems and drug product solutions</li><li>Utilize advanced mass spectrometry techniques (LC-MS and GC-MS) for identification and quantification of Nitrosamines</li><li>Prepare technical reports and support documentation for regulatory filings</li><li>Collaborate with subject matter experts, supervisors, and cross-functional teams</li><li>Interpret analytical data, evaluate results, and incorporate findings into project goals</li><li>Maintain compliance with relevant Quality System Regulations and GxP standards</li></ul> Requirements: <ul><li>Experience: 6–10 years in analytical chemistry focused on Nitrosamines</li><li>Education: Master’s degree or equivalent experience; PhD preferred with relevant experience</li><li>Skills Required:</li><li>Proficiency in LCMS/GCMS instrumentation and troubleshooting</li><li>Strong knowledge of Nitrosamine chemistry and analytical techniques</li><li>Experience in method development, validation, and regulatory reporting</li><li>Ability to analyze complex data and draw meaningful conclusions</li><li>Good documentation and technical report writing skills</li></ul>

Role Description: <ul><li>The Manager –ADL, GM P is responsible for leading analytical development activities within a GMP-regulated environment, ensuring robust method development, validation, and transfer for pharmaceutical products.</li><li>This role plays a critical part in supporting product development, regulatory submissions, and commercial manufacturing by providing accurate and compliant analytical data.</li></ul> Responsibilities <ul><li>Lead and manage a team involved in method validation, method transfer, and postproduction studies (Freeze Thaw analysis, Photostability studies, Dilution studies, RLD Characterization, etc.) for 505b(2) and generic ANDAs.</li><li>Troubleshoot and resolve challenges during method validation and method transfer of new products from R&amp;D to manufacturing sites.</li><li>Support regulatory filings and respond to analytical function queries.</li><li>Ensure compliance with cGLP within the ADL GMP function.</li><li>Provide support during quality inspections by regulatory agencies at manufacturing plants.</li><li>Timely closure of LIR, NCR, CCN, CAPA and ensure implementation of corrective and preventive actions.</li><li>Ensure timely compliance with Pharmacopoeia updates.</li><li>Mentor, coach, and develop team members for task execution and personal growth.</li><li>Collaborate with external partners (CRO/CMO) for analytical testing execution.</li><li>Work cross-functionally with project management, regulatory affairs, formulation development, manufacturing, and quality control teams.</li></ul> Requirements: <ul><li>Education: Ph.D. OR MPharm.</li><li>Experience: 3–4 years of team handling experience.</li></ul> Skills Required: <ul><li>Strong knowledge of analytical method validation, method transfer, Pharmacopoeia compliance, cGLP, and documentation practices.</li><li>Sound understanding of analytical techniques with good learning agility.</li><li>Excellent technical writing and computer skills for data recording, protocol/report generation, and presentations.</li><li>Strong coordination, relationship management, and ability to work in multicultural teams.</li><li>Effective communication and team management skills.</li><li>Knowledge of latest quality and regulatory requirements.</li><li>Ability to delegate effectively and take autonomous decisions.</li><li>Critical thinking skills for problem-solving and decision making.</li></ul>

Job Description: <ul><li>The role of a Manager – R&amp;D (Research &amp; Development) F&amp;D (Food &amp; Drink) Emulsions typically involves overseeing the research, development, and innovation of emulsions used in the food and beverage industry.&nbsp;</li><li>The manager leads the R&amp;D team to develop new emulsion-based products or improve existing ones to meet customer requirements, industry standards, and market demands.</li></ul> Responsibilities: Planning of Project technical feasibility experiment: <ul><li>End to end planning for Resource availability on time Planning of developmental trials, PDR studies/QBD additional studies for ANDA products</li><li>Planning of developmental trials, PDR studies/QBD additional studies for ANDA products.</li><li>Monitoring of development trials.</li><li>Compilation of the development data.</li><li>Ensuring development as per QBD approach</li><li>Review the technical documents e.g. DMBD, PDR and other protocols &amp; reports.</li><li>Coordination with CFTs (ADL, IRA, Procurement, Quality) for on time project execution.</li><li>Technology transfer of Drug product [ANDA, 505 (b)(2), Complex injectables]</li><li>Exhibit batch execution [ANDA, 505 (b)(2), Complex injectables]</li><li>Support for Process validation and commercial batches [ANDA, 505 (b)(2), Complex injectables]</li><li>Technology transfer documents review Products developed by CRO as per regulatory requirement.</li><li>Support &amp; coordination with CMOs for successful technology transfer</li><li>Fulfilling the regulatory requirements by designing the trials</li><li>Training &amp; knowledge enhancement of the team</li><li>Design &amp; Authorization of SOPs</li><li>Execution &amp; approval process of New Equipments/Instruments for projects in upcoming portfolio &amp; continuous improvement of Development Lab.</li><li>Adoption of GQP (Procedures integration with systems)</li></ul> Requirements: <ul><li>3–4 years of team handling experience</li><li>3–4 years of hands-on work in emulsions (oil-based and water-based)</li><li>Full product lifecycle exposure: development → scale-up → filing</li><li>Minimum 5–10 regulatory filings (e.g., ANDA, NDA)</li><li>Strong people management and leadership capabilities</li><li>Preferred experience in ophthalmic formulations</li><li>Background in injectable manufacturing environment is an added plus</li></ul>

Responsibilities: <ul><li>Develop, implement, and optimize manufacturing processes to improve efficiency, quality, and cost-effectiveness.</li><li>Provide technical support for new product introduction (NPI), including process design, tooling, and equipment validation.</li><li>Conduct root cause analysis and lead corrective/preventive actions (CAPA) to&nbsp;</li><li>resolve production issues.</li><li>Collaborate with cross-functional teams (R&amp;D, Quality, Supply Chain, Maintenance) to ensure smooth project execution and production readiness.</li><li>Prepare and maintain process documentation, work instructions, and training materials.</li><li>Monitor key production metrics (yield, scrap, cycle time, downtime) and implement continuous improvement initiatives.</li><li>Participate in lean manufacturing, Six Sigma, and Kaizen activities to drive operational excellence.</li><li>Ensure compliance with safety standards, environmental regulations, and ISO/IATF quality system requirements.</li><li>Support cost reduction projects through process improvement, automation, and supplier collaboration.</li></ul> Requirements: <ul><li>Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field.</li><li>3–5 years of relevant experience in manufacturing engineering; automotive or electronics industry experience preferred.</li><li>Strong knowledge of manufacturing processes such as machining, assembly, injection molding, stamping, or PCB assembly (depending on industry).</li><li>Familiarity with APQP, PPAP, FMEA, Control Plan, and other quality tools.</li><li>Proficiency in CAD software (e.g., AutoCAD, SolidWorks, Creo) and MS Office.</li><li>Hands-on experience with Lean Manufacturing and problem-solving methodologies (5Why, 8D, DMAIC).</li><li>Good communication and coordination skills; able to work in cross-functional and multicultural teams.</li><li>English: able to read and write technical documents; spoken English is a plus.</li></ul>

Role Description: <ul><li>The Facility Engineer will play a critical role in the greenfield design, construction, startup, and long-term operation of a state-of-the-art sterile injectable IV bag manufacturing facility. This role will lead the implementation and management of all facility infrastructure systems, including cleanrooms, HVAC, utilities, building automation, environmental monitoring, chemistry and microbiology lab systems, and energy management, ensuring full compliance with cGMP standards and regulatory expectations for sterile manufacturing.</li><li>The Facility Engineer will collaborate with cross-functional teams during construction, commissioning, qualification, and beyond, ensuring the facility infrastructure reliably supports sterile production, patient safety, and long-term business goals.</li></ul> Responsibilities: <ul><li>Lead the design review, specification development, and technical oversight of facility infrastructure systems including cleanrooms, HVAC, compressed air, chilled water, WFI, clean steam, and other critical utilities.</li><li>Develop and maintain facility engineering standards, equipment specifications, and technical documentation aligned to regulatory requirements and aseptic processing standards.</li><li>Oversee construction, installation, commissioning, and qualification of facility utilities and infrastructure systems, ensuring timely, compliant project execution.</li><li>Collaborate with Validation, Quality, and Operations teams to ensure proper facility qualification (IQ/OQ/PQ) and environmental monitoring readiness.</li><li>Promote and ensure adherence to safety protocols and safe work practices.</li><li>Perform risk assessments for engineering and maintenance activities.</li><li>Establish and manage preventative maintenance programs, calibration schedules, and facilities management SOPs to ensure optimal equipment performance and facility reliability.</li><li>Provide technical expertise in troubleshooting facility system deviations, non-conformances, and CAPAs, ensuring timely resolution and sustained compliance.</li><li>Partner with EHS, Operations, and Quality to ensure all facility systems meet safety, regulatory, and operational expectations.</li><li>Manage relationships with external engineering firms, contractors, and utility service providers to ensure effective delivery of construction and facility services. 11.	Support energy management, sustainability initiatives, and continuous improvement efforts to optimize facility operating costs and resource utilization.</li><li>Ensure ongoing regulatory inspection readiness and serve as SME for facility systems during audits and inspections.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in mechanical, Electrical, Industrial, or Facilities Engineering.</li><li>3+ years of relevant experience in pharmaceutical or sterile manufacturing facility engineering.</li><li>Strong technical knowledge of facility infrastructure systems including HVAC for aseptic manufacturing, cleanrooms, and critical utilities.</li><li>Direct experience with greenfield facility construction, commissioning, and qualification highly desirable.</li><li>Solid understanding of FDA cGMP regulations, USP standards, and applicable environmental, health, and safety requirements.</li></ul> Skills/Competencies: <ul><li>Expertise Experience in facility system design, commissioning, and lifecycle maintenance.</li><li>Strong project management and contractor/vendor coordination capabilities.</li><li>Excellent problem-solving and root cause analysis skills.</li><li>Strong understanding of aseptic manufacturing facility requirements and environmental controls.</li><li>Effective communication and cross-functional collaboration skills.</li><li>High attention to detail, safety, and compliance.</li><li>Ability to thrive in a dynamic greenfield/startup environment.</li></ul>

Role Description: <ul><li>The Document Control Lead will serve as a key quality function responsible for establishing, maintaining, and managing the document control systems critical to ensuring regulatory compliance, data integrity, and operational readiness for a greenfield sterile injectable IV bag manufacturing facility.</li><li>This role will drive the creation, organization, distribution, and maintenance of all controlled documentation required to support GMP operations, regulatory submissions, and inspection readiness.</li><li>The incumbent will play a vital role in building document management systems during site startup and ensure robust control throughout the facility lifecycle.</li><li>This role will also be the site technical resource for coordination and qualification of corporate quality electronic document systems including Trackwise, Learning Management System, and the Document Control System.</li></ul> Responsibilities: <ul><li>Develop and implement comprehensive document control systems aligned with FDA cGMP, ICH, ISO, and company quality standards.</li><li>Manage the creation, review, approval, issuance, and archival of controlled documents including SOPs, batch records, forms, protocols, and reports.</li><li>Establish electronic document management systems (EDMS) and ensure proper system validation and security controls are in place.</li><li>Lead training initiatives for site personnel on document control processes, document authoring standards, and compliance requirements.</li><li>Coordinate cross-functional document reviews, version control, change management, and timely issuance of current documents to ensure operational readiness.</li><li>Monitor and ensure compliance with controlled document workflows, ensuring timely processing and adherence to procedural timelines.</li><li>Support regulatory inspections, internal audits, and external audits by providing controlled document access, retrieval, and documentation support.</li><li>Maintain accurate and organized archives (both physical and electronic) to ensure data integrity, traceability, and inspection readiness.</li><li>Collaborate with Quality Assurance, Validation, Operations, Engineering, and Regulatory Affairs to ensure alignment of document control processes.</li><li>Continuously improve document control processes, leveraging automation, best practices, and compliance trends to ensure long-term system robustness.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in Life Sciences, Quality Management, or related field.</li><li>5+ years of experience in GMP-regulated pharmaceutical document control, preferably in sterile manufacturing.</li><li>Prior experience implementing or managing electronic document management systems (EDMS) strongly preferred.</li><li>Strong understanding of FDA cGMP, ICH, ISO 9001, and data integrity principles.</li><li>Experience supporting regulatory inspections and audits.</li></ul> Skills/Competencies: <ul><li>Expertise in controlled document management principles and electronic systems.</li><li>Strong attention to detail, accuracy, and compliance.</li><li>Excellent organizational and time management skills.</li><li>Ability to manage multiple priorities and document workflows simultaneously.</li><li>Strong cross-functional collaboration and communication skills.</li><li>Proficiency in EDMS platforms, document lifecycle management, and version control.</li><li>Ability to work in a greenfield/startup environment and build systems from the ground up.</li></ul>

Role Description: <ul><li>The Process Equipment Engineer will be a key technical leader responsible for the design, specification, procurement, installation, qualification, and ongoing reliability of process equipment for a greenfield sterile injectable IV bag manufacturing facility.</li><li>This role will play a critical part in ensuring that all manufacturing equipment all sterile manufacturing equipment are compliant with cGMP requirements, supports aseptic processing standards, and are capable of delivering high-quality product performance from day one of commercial operations. </li><li>Equipment includes sterile isolators, compounding, automated inspection, and secondary packaging for the production of sterile IV bags.</li><li>Working cross-functionally during the startup phase, the incumbent will drive equipment readiness, validation support, and serve as a technical subject matter expert (SME) for process equipment throughout the facility lifecycle.</li></ul> Responsibilities: <ul><li>Lead the specification, selection, and procurement of sterile injectable manufacturing process equipment, including isolator filling lines, formulation vessels, mixing systems inspection equipment, secondary packaging equipment, and associated support systems.</li><li>Develop user requirement specifications (URS), functional specifications (FS), and detailed equipment design documentation in compliance with regulatory and operational standards.</li><li>Manage equipment vendors, design reviews, factory acceptance testing (FAT), site acceptance testing (SAT), and oversee equipment delivery, installation, and commissioning.</li><li>Promote and ensure adherence to safety protocols and safe work practices.</li><li>Perform risk assessments for engineering and maintenance activities.</li><li>Collaborate with Validation, Quality, and Operations teams to support equipment qualification (IQ/OQ/PQ) and ensure all systems meet regulatory expectations for sterile manufacturing.</li><li>Establish preventative maintenance programs, spare parts inventories, and equipment lifecycle management plans to ensure long-term equipment reliability and availability.</li><li>Provide technical expertise during troubleshooting, deviations, and investigations related to process equipment performance, ensuring rapid resolution of issues.</li><li>Partner with Manufacturing and Quality teams to optimize equipment performance, drive continuous improvement initiatives, and support ongoing process optimization.</li><li>Identify and implement process improvements to enhance operational safety, efficiency, and reliability.</li><li>Support development of SOPs, equipment manuals, and operator training programs to ensure safe and compliant operation of process equipment.</li><li>Ensure equipment designs fully comply with cGMP, FDA, OSHA, and all applicable regulatory and safety standards.</li><li>Contribute to capital project planning, budgeting, and project execution related to new equipment or facility expansions.</li><li>Ensure ongoing regulatory inspection readiness and serve as SME for process systems during audits and inspections.</li></ul> Requirements: <ul><li>Bachelor’s degree in mechanical engineering, Chemical Engineering, Industrial Engineering, or related field.</li><li>3+ years of experience in pharmaceutical process equipment engineering, with significant exposure to sterile injectable manufacturing strongly preferred.</li><li>Direct experience with design, procurement, and qualification of aseptic manufacturing equipment and cleanroom environments.</li><li>Solid understanding of cGMP regulations, FDA/EMA expectations, and engineering best practices for sterile operations.</li><li>Experience working in greenfield or major facility expansion projects highly desirable.</li></ul> Skills/Competencies: <ul><li>Strong technical knowledge of process equipment design, aseptic manufacturing, and utility systems.</li><li>Proven project management skills with ability to handle complex, cross-functional projects.</li><li>Excellent problem-solving abilities and root cause investigation experience.</li><li>Effective communication and vendor management skills.</li><li>Ability to work independently in a fast-paced, startup-like environment.</li><li>Strong teamwork, collaboration, and continuous improvement mindset.</li><li>High attention to detail with strong commitment to safety, compliance, and product quality.</li></ul>

Responsibilities: <ul><li>Contribute to planning, estimation, and refinement of stories, epics, and design changes as part of an Agile Scrum team.</li><li>Build out test strategies and plans to cover new areas of functionality, ensuring all necessary testing is performed.</li><li>Refine acceptance criteria into testable units and convert those into automated tests that execute efficiently and reliably.</li><li>Integrate automated tests with CI/CD pipelines and ensure successful automation as part of our standard build process.</li><li>Occasional manual testing when automation is not an option.</li><li>Report, reproduce, and help development resolve defects, emphasis on troubleshooting, root cause analysis, and prevention of similar issues in the future.</li><li>Freely debate ideas and rally behind decisions.</li><li>Pushing for continual improvement in everything we do.</li><li>Apply technology trends and industry innovations to our products and take initiatives.</li><li>Utilizing and embracing AI tools to assist in Quality Engineering activities.</li></ul> Requirements: <ul><li>Domain experience in Quality Engineering, especially automated testing.</li><li>Experience test planning and breaking down stories/requirements into testable units.</li><li>Full-stack experience in automated testing, validating both front-end and back-end interfaces, including RESTful API endpoints and web-based user interfaces.</li><li>Solid object-oriented programming skills and string experience automating in Java, JavaScript, typescript or similar.</li><li>Experience on building and scaling tests using frameworks like Junit/TestNg and/or Cypress/Playwright.</li><li>Experience/familiarity working with public cloud, especially AWS and utilising its SDK to interact with Cloud Services for testing.</li><li>Familiarity working with databases and an ability to incorporate database-side validation into automated tests.</li><li>Experience with CI/CD pipelines, especially using Jenkins and working with pipelines.</li><li>Some working knowledge of Microsoft Exchange, Microsoft 365, Azure Active Directory, and Windows Server.</li><li>Experience/knowledge in leveraging AI tools in building agents, using for reviews and generating skeleton code.</li><li>Some experience/familiarity with performance/scalability testing.</li><li>Bias for action and problem solving – eagerness to take initiative and make things happen.</li></ul>

Role Description:&nbsp; <ul><li>As a Wire/Cable Senior R&amp;D/Product Development Engineer at our clienty, you will work in a dynamic, diverse environment focusing on the development and qualification of high-speed bulk cable products.</li><li>This role supports the full product lifecycle—from concept and design through testing, production, and release—while collaborating across engineering, manufacturing, and customer teams.</li></ul> Responsibilities:&nbsp; <ul><li>Lead the design, specification, and documentation of bulk cable Signal Integrity (SI) and physical testing interfaces for high-speed bulk cable applications.</li><li>Interact with Cable Assembly SI teams to correlate bulk cable data with cable assembly SI/physical test results.</li><li>Collaborate with customers and end-users to understand use case requirements and establish test specifications aligned with industry standards.</li><li>Work with internal and external vendors to design and implement test equipment and fixtures.</li><li>Develop, document, and maintain bulk cable SI/physical test protocols.</li><li>Train bulk cable test personnel across all our client DDN bulk cable locations on the use of testing fixtures and procedures.</li><li>Deliver technical presentations to both internal teams and external customers as needed.</li><li>Support and participate in company safety (SAFE) and ISO compliance activities.</li><li>Provide technical support for maintenance and calibration of bulk cable test equipment.</li><li>Contribute to cross-functional projects and initiatives supporting business objectives.</li></ul> Requirements:&nbsp; <ul><li>Strong knowledge of circuit analysis&nbsp;</li><li>Experience with reliability testing and engineering.</li><li>Proficient in using Network Analyzers and working with S-Parameters.</li></ul>

Responsibilities:&nbsp; <ul><li>Lead process development, implementation, and documentation for bulk cable manufacturing.</li><li>Support product/process validation and transfer activities.</li><li>Assist with product qualification, working closely with engineering and test lab teams.</li><li>Partner with Product Development/Design Engineering to ensure manufacturability.</li><li>Interact with test laboratories on process/product qualification tasks, including DOE, PFMEA, 8D investigations, and Failure Analysis (FA).</li><li>Support tooling specification and design for manufacturing processes.</li><li>Provide engineering support to additional manufacturing sites as required.</li><li>Collaborate with suppliers to ensure process compliance and capability.</li><li>Support SAFE (Safety Activities For Employees) and ISO quality compliance initiatives.</li><li>Provide technical support for manufacturing maintenance activities.</li><li>Participate in cross-functional projects that support business growth and continuous improvement.</li></ul> Requirements:&nbsp; <ul><li>Strong knowledge of materials, processes, and systems used in wire and cable manufacturing.</li><li>Proficient in CAD software for tooling and process design.</li><li>Practical knowledge and experience with SPC (Statistical Process Control), Six Sigma, and Lean Manufacturing principles.</li><li>Ability to manage multiple projects and deliver results under tight timelines.</li><li>Willingness to travel internationally up to 30% as required.</li></ul>

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19 validation Jobs found

Research Associate – II Nitrosamines

Manager – ADL GMP

Manager – R&D F&D Emulsions

Manufacturing Engineer

Facility Engineer

Document Control Lead

Process Equipment Engineer

Software Development Engineer in Test

Wire/Cable Senior R&D/Product Development Engineer

Manufacturing & Process Development Engineer II (Wire & Cable)

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19 validation Jobs found

Research Associate – II Nitrosamines

Manager – ADL GMP

Manager – R&D F&D Emulsions

Manufacturing Engineer

Facility Engineer

Document Control Lead

Process Equipment Engineer

Software Development Engineer in Test

Wire/Cable Senior R&D/Product Development Engineer

Manufacturing & Process Development Engineer II (Wire & Cable)

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.