QC Chemist

Microbiology Technician

Central Demand Planner

Staff Simulation Engineer - CFD

Test

Senior QA Automation Engineer

Supervisor – Quality and Reliability Engineer

Manager II – Quality & Reliability Engineering

Sr. Analyst – Enterprise Systems

Technical Product Manager

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 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>Lead the Global Demand Planning Cycle of the S&amp;OP process: Own and execute the monthly demand process from system handover to consensus sign-off. </li><li>Coordinate inputs from Sales, Product Management, and Finance, and ensure outputs feed into supply planning and S&amp;OP.</li></ul> Improve Forecast Accuracy:&nbsp; <ul><li>Drive measurable improvements in MAPE, Bias, and Forecast Adherence. Use data-driven techniques and root-cause analysis to understand gaps and implement corrective actions.</li></ul> Bridge Strategy and Execution:&nbsp; <ul><li>Translate commercial assumptions and market intelligence into an aligned, actionable forecast that drives capacity, procurement, and financial planning.</li></ul> Advance Tools and Reporting:&nbsp; <ul><li>Develop and maintain robust forecasting reports and KPIs using Excel, Power BI (or Tableau), and SAP IBP. </li><li>Push the team toward automated, visual, and insightful reporting.</li><li>Facilitate Consensus and Governance: Orchestrate monthly consensus meetings and prepare executive-ready materials that clearly communicate changes, assumptions, and risks.</li></ul> Support Constrained Planning:&nbsp; <ul><li>Collaborate with the Supply Planner to identify constraint-driven adjustments and simulate scenarios to evaluate trade-offs.</li><li>Enhance Collaboration and Accountability: Act as the single point of contact for demand planning across regions. Push for timely inputs, challenge assumptions, and ensure cross-functional accountability.</li></ul> Lead Process Improvements:&nbsp; <ul><li>Identify inefficiencies and design solutions—whether it’s template optimization, system enhancements, or training stakeholders on best practices.</li></ul> Support S&amp;OP Strategy:&nbsp; <ul><li>Contribute actively to the broader S&amp;OP cycle, including confidence-level strategies, forecast version control, and long-range planning exercises.</li></ul> Requirements: <ul><li>Bachelor’s degree in supply chain, Engineering, Business, or related field; Master’s preferred</li><li>Minimum 5 years of experience in demand planning or S&amp;OP in a multinational environment</li><li>Demonstrated ability to work independently and proactively influence cross-functional teams</li><li>High proficiency in Excel and Power BI (or Tableau); experience with SAP IBP is strongly preferred</li><li>Strong business acumen and communication skills; able to translate data into decisions</li><li>Fluent in English</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>Together with the team of developers handle the product quality.</li><li>Lead and manage the automation testing efforts and deliverables.</li><li>Plan and prioritize testing activities.</li><li>Maintain and improve an existing test automation framework.</li><li>Develop automation tests for API and UI.</li><li>Execute, maintain and update automation tests.</li><li>Review and analyze tests execution results.</li><li>Maintain all related test documentation.</li><li>Prepare testing data.</li><li>Proactively acquire and clarify requirements as necessary.</li><li>Mentor less skilled teammates and newcomers.</li></ul> Requirements: <ul><li>Strong knowledge of OOP (understanding OOP in automation).</li><li>Excellent knowledge of automation testing principles.</li><li>Excellent knowledge of web-based application structure.</li><li>Excellent knowledge of Python programming language.</li><li>Expert in REST API testing.</li><li>Experience in UI testing.</li><li>Wide experience in developing automation testing frameworks.</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: <ul><li>Configure, implement, enhance, support, and test applications supporting global SAP Finance functions.</li><li>Develop and improve a new global SAP S4 template, with a rollout planned over the next 3–5 years.</li><li>Participate in SAP implementation projects, focusing on Finance and Controlling areas and integration points with logistics modules (SD/MM/PP).</li><li>Prepare and execute master data and transactional data migration activities.</li><li>Define Finance data standards and governance rules.</li><li>Provide training to business and project teams as required.</li><li>Identify, evaluate, and implement opportunities to improve systems and procedures, including documenting business requirements, designing, and implementing solutions.</li><li>Prepare development specifications and collaborate with technical experts to design and test new programs or changes to existing programs. Serve as a project lead on SAP projects as required.</li><li>Work closely with all levels of staff within shared service finance and Business Unit (BU) controlling organizations.</li><li>Collaborate with the external AMS provider to continuously improve services for our client SAP ECC platforms and S4 system.</li></ul> Requirements: <ul><li>Bachelor’s degree in Computer Science, Information Systems, Business Administration with a Finance concentration, or equivalent experience.</li><li>Experience in SAP S4 with a complete project cycle.</li><li>Experience in SAP ECC Finance and Controlling.</li><li>Ability to work independently while meeting shifting deadlines.</li><li>Strong interpersonal skills to interact with staff and management at various levels.</li><li>Ability to understand and translate business needs into technical solutions.</li><li>Project management skills.</li><li>Strong analytical skills to investigate user issues and provide resolutions.</li><li>Ability to adapt to changing user requirements and business environments.</li></ul>

Responsibilities: <ul><li>Collaborate with stakeholders to define product requirements and roadmap.</li><li>Translate customer needs into clear and actionable technical specifications.</li><li>Write and refine business requirements and acceptance criteria.</li><li>Work closely with product managers to prioritize the backlog in JIRA.</li><li>Work closely with engineering teams to ensure successful and timely product development and delivery.</li><li>Act as the primary liaison between business stakeholders, clients, and technical teams.</li><li>Run cross-functional meetings and facilitate decision-making.</li><li>Provide transparency on product status, risks, and dependencies.</li><li>Review and test deliverables to ensure they meet business requirements.</li></ul> Requirements: <ul><li>Strong technical background with knowledge of blockchain technology and distributed systems.</li><li>Experience with Agile/Scrum methodologies and product management tools such as JIRA.</li><li>Excellent problem-solving and analytical skills.</li><li>Strong communication and leadership abilities.</li><li>Strong organizational and facilitation skills.</li><li>Ability to work effectively in a fast-paced, dynamic environment.</li><li>Collaborative team player with the ability to influence without authority.</li></ul>

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56 test scenarios Jobs found

QC Chemist

Microbiology Technician

Central Demand Planner

Staff Simulation Engineer - CFD

Test

Senior QA Automation Engineer

Supervisor – Quality and Reliability Engineer

Manager II – Quality & Reliability Engineering

Sr. Analyst – Enterprise Systems

Technical Product Manager

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56 test scenarios Jobs found

QC Chemist

Microbiology Technician

Central Demand Planner

Staff Simulation Engineer - CFD

Test

Senior QA Automation Engineer

Supervisor – Quality and Reliability Engineer

Manager II – Quality & Reliability Engineering

Sr. Analyst – Enterprise Systems

Technical Product Manager

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

EMPLOYER

TALENT

COMPANY

Contact Us

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