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)

Validation Manager

HR Manager

Senior R&D Product Development Engineer (HVAC)

Business Analyst

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>

Responsibilities: <ul><li>Serve as the site Validation SME, overseeing all validation activities, including process, cleaning, equipment, utility, and computer system validation.</li><li>Own and maintain the Validation Master Plan (VMP), ensuring alignment with regulatory expectations, site activities, and company objectives.</li><li>Develop, implement, and maintain the site validation lifecycle program, including process validation, performance qualification (PQ), and CPV.</li><li>Lead validation planning and coordination efforts for new equipment, systems, and process changes in collaboration with Engineering, Manufacturing, and Quality.</li><li>Manage validation project timelines and resource allocation, ensuring activities support commercial readiness and ongoing operations.</li><li>Review and approve validation protocols, reports, and risk assessments in compliance with FDA, EMA, ICH Q8-Q10, EU Annex 15, and company standards.</li><li>Support and participate in cross-functional risk assessments (e.g., FMEA) related to qualification and validation efforts.</li><li>Ensure validation documentation is complete, accurate, and audit ready.</li><li>Provide guidance and technical expertise during regulatory inspections, audits, and customer assessments.</li><li>Develop and maintain the site’s Continuous Process Verification (CPV) program to monitor validated state and process performance over time.</li><li>Define and monitor KPIs for validation program effectiveness and drive improvements in validation efficiency and compliance.</li><li>Train and mentor staff on validation principles and procedures to build internal capability across departments.</li><li>Ensure change control, deviation management, and CAPA processes integrate appropriately with validation and qualification requirements.&nbsp;</li></ul> Key Stakeholders: Internal: <ul><li>Site Quality, Manufacturing, and Engineering Teams</li><li>Technical Services, Supply Chain, and EHS</li><li>Validation Analysts and Support Staff</li><li>Corporate Validation and Quality Teams</li></ul> External: <ul><li>Regulatory Agencies (FDA, EMA, etc.)</li><li>Equipment and system vendors</li><li>Contract testing laboratories</li><li>Third-party auditors and certifying bodies</li></ul> Requirements; Qualifications / Experience: <ul><li>Bachelor’s degree in engineering, Life Sciences, Pharmacy, or related discipline; Master’s preferred</li><li>Minimum 10-12 years of experience in pharmaceutical or biotechnology validation, with at least 3 years in a leadership or SME role</li><li>Validation of sterile injectable equipment expertise required</li><li>Strong knowledge of FDA cGMPs, ICH Q8–Q10, EU Annex 15, and validation best practices</li><li>Experience with sterile injectable manufacturing, aseptic processes, utilities, and equipment qualification</li><li>Experience with controlled substances and high-potency compounds preferred</li><li>Proven experience supporting regulatory inspections and third-party audits</li><li>Experience with commissioning, qualification, and validation in a startup (greenfield) or expansion environment preferred </li></ul> Skills / Competencies: <ul><li>Strong technical writing and documentation review skills</li><li>Ability to manage multiple projects and prioritize in a fast-paced environment</li><li>Expertise in sterile systems, process validation, cleaning validation, and computer system validation</li><li>Excellent cross-functional communication, influencing, and collaboration skills</li><li>Strong analytical, risk-based decision-making, and problem-solving skills</li><li>Leadership presence with ability to coach and mentor others in validation principles</li><li>Commitment to data integrity, patient safety, and product quality</li></ul>

Responsibilities: <ul><li>Lead the HR function at the site to support business objectives and compliance with HR best practices.</li><li>Serve as a trusted advisor to site leadership on workforce planning, employee relations, and organizational development.</li><li>Partner with corporate HR, Quality, EHS, and Operations to align policies, procedures, and culture-building initiatives.</li><li>Initiate and nurture a positive employee relations environment through coaching, communication, and conflict resolution.</li><li>Ensure compliance with federal, state, and local labor laws, as well as cGMP and safety-related employee policies.</li><li>Maintain accurate and confidential employee records, including training and medical surveillance, in cooperation with the EHS Lead.</li><li>Develop, implement, and manage the Learning Management System (LMS) for GMP and technical training.</li><li>Implement employee engagement strategies to nurture a culture of integrity, teamwork, and compliance.</li><li>Administer compensation and benefits programs, including health, retirement, and wellness plans</li><li>Manage payroll coordination with Finance team.</li><li>Monitor and report on key HR metrics (e.g. headcount, turnover, training compliance, absenteeism, engagement)</li><li>Lead the annual organizational review and individual development program.</li></ul> Key Stakeholders: Internal: <ul><li>Site Leadership Team (Operations, Quality, Engineering, Warehouse, Finance, EHS)</li><li>Corporate HR</li><li>Manufacturing and Technical Services Teams</li><li>Validation and Project Management Teams</li></ul> External: <ul><li>FDA and other regulatory agencies</li><li>Third-party auditors and certifying bodies</li><li>External HR service providers</li><li>Customers and business partners</li></ul> Requirements: <ul><li>Bachelor’s degree in human resources, Business Administration, or related field (Master’s or HR certification preferred).</li><li>Minimum 5–10 years of progressive HR experience, including at least 3 years in a manufacturing or GMP-regulated environment and 3 years on site leadership team (pharma, biotech, or medical device strongly preferred).</li><li>Experience supporting high-growth or startup operations is highly desirable.</li></ul> Skills / Competencies: <ul><li>Strong understanding of HR compliance, labor laws, and best practices.</li><li>Demonstrated ability to build HR systems, processes, and policies from the ground up.</li><li>Demonstrated ability to improve HR systems and drive improved engagement and performance.</li><li>Excellent interpersonal, communication, and problem-solving skills.</li><li>Comfortable working in a fast-paced, evolving environment where agility and adaptability are key.</li><li>Strong leadership presence with demonstrated ability to build high-performing teams and compliance culture.</li><li>Effective communication, collaboration, and influencing skills across multiple stakeholders.</li></ul>

Responsibilities: <ul><li>Work within a global multidisciplinary team environment as Product Engineering lead to design and develop functionally robust and cost-effective Connector products / processes to meet customer and market needs</li><li>Deliver regional and global NPD projects which includes activities like Concept generation, Concept validation, tolerance stack analysis, DFMEA, conduct design reviews, basic FEA simulation, Creation of detailed designs and drawings in CREO by applying DFM/DFA principles, creation of product validation / Qualification test plans, perform component fit and function analysis.</li><li>Execute Sustaining activities of legacy products like Customer queries, field failures, address design related manufacturing concerns, BOM &amp; change management in windchill, product improvements, necessary product design documentation/specification updates.</li></ul> Requirements: Knowledge, Skills, Abilities:&nbsp; <ul><li>Expert in design and development of Sheetmetal and Plastic products</li><li>Deep knowledge of associated manufacturing processes (moulding, stamping, plating and Assy)</li><li>Knowledge of materials, finishes and contact physics related to interconnection design</li><li>Knowledge of wire termination techniques (crimping, soldering, welding etc.)</li><li>Experience of testing requirements and techniques for product qualification</li><li>Knowledge of Voice of Customer, Design to Value, Design for Six Sigma.</li><li>General knowledge of industry specifications such as UL, CSA, IEC, and EIA are desirable.</li></ul> Education, Technical Qualification:&nbsp; <ul><li>Bachelor’s degree in Mechanical Engineering/Design</li><li>Min. 9+ years components design related experience</li></ul>

Responsibilities: <ul><li>Collaborate with business users, subject matter experts, and technical teams to gather and analyze requirements for blockchain-based software solutions.</li><li>Conduct interviews, workshops, and document analysis to understand current business processes and identify opportunities for blockchain-driven improvements.</li><li>Create detailed requirement specifications, including use cases, user stories, process flows, and data models.</li><li>Prioritize requirements based on business value and technical feasibility in collaboration with stakeholders.</li><li>Facilitate discussions and manage stakeholder expectations, building consensus across diverse teams.</li><li>Work within an Agile development framework, participating in sprint planning, reviews, and retrospectives.</li><li>Translate business requirements into functional specifications and support the development team during implementation.</li><li>Conduct validation and acceptance testing to ensure the solution meets business needs.</li><li>Continuously evaluate solution performance and gather feedback for future enhancements.</li></ul> Requirements: <ul><li>Bachelor’s degree in Business Administration, Finance, Computer Science, or a related field.</li><li>Minimum of 3 years of experience as a business analyst, preferably in the financial sector.</li><li>Strong understanding of blockchain technology and its applications in finance.</li><li>Experience with Agile methodologies and Scrum governance.</li><li>Excellent communication and interpersonal skills.</li><li>Proven ability to work effectively with diverse stakeholders and cross-functional teams.</li></ul>

Skills

Industry

Location

Jobtitle

33 validation Jobs found

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)

Validation Manager

HR Manager

Senior R&D Product Development Engineer (HVAC)

Business Analyst

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

Skills

Industry

Location

Jobtitle

33 validation Jobs found

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)

Validation Manager

HR Manager

Senior R&D Product Development Engineer (HVAC)

Business Analyst

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

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.