Quality Engineer

Senior Project Manager Engineer

QC Chemist

Senior Microbiology Technician

Microbiology Technician

Digital Factory Engineer

Staff Software Engineer(Enterprise)

Staff Software Engineer (Auth0)

Staff Quality & Reliability Engineer

Mechanical Engineer

Responsibilities: Provide review and drive to approval of the validation protocols and reports for facility, equipment, laboratory instrument, and utility systems. <ul><li>Review and approval of technology/method transfer protocols and reports.</li><li>Review and evaluation of change controls</li><li>Review and approval of deviations and assurance that they define root causes and determine appropriate CAPA.</li><li>Participate in cross-functional teams to support execution of commissioning, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and validation protocols.</li><li>Provide quality presence during qualification execution, ensuring data integrity, deviation management, and proper documentation of results.</li><li>Support the timely review and approval of executed qualification documentation and ensure readiness for inspection or submission.</li><li>Drive timely and compliant resolution of deviations, non-conformances, and CAPAs arising during operations and qualification activities.</li><li>Develop, implement, and maintain site-specific quality procedures (SOPs, work instructions, forms) governing validation, change control, deviation, and other SOPs relevant to the responsibilities</li><li>Review and approve site procedures to ensure clarity and compliance with cGMP standards.</li><li>Ensure proper execution of Good Documentation Practices (GDP) in all QA-reviewed documents, including validation records, logbooks, and manufacturing records.</li><li>Act as a QA representative during regulatory inspections, internal audits, and customer audits, with emphasis on operational and qualification-related topics.</li><li>Monitor key quality metrics and drive performance improvements in areas such as deviation reduction, batch record right-first time, and qualification readiness.</li><li>Contribute to the continued inspection readiness of the site, including periodic walkthroughs and risk-based quality improvements.</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in engineering or technical discipline (e.g., engineering, Biology, Chemistry, Pharmacy).</li><li>5+ years of experience in pharmaceutical manufacturing QA, including direct involvement in qualification/validation activities.</li><li>Prior experience reviewing or approving qualification protocols and validation reports in GMP environments.</li><li>Familiarity with aseptic manufacturing, sterile injectable processes, and cleanroom environments.</li><li>Knowledge of FDA cGMPs, ICH Q8-Q10 guidelines, EU Annex 1, and risk-based qualification approaches.</li><li>Experience supporting regulatory inspections and validation documentation reviews.</li></ul> Skills/Competencies <ul><li>Strong knowledge of validation principles and qualification documentation expectations.</li><li>Effective team leader with experience supervising QA staff and coordinating cross-functional support.</li><li>Excellent organizational and communication skills with high attention to detail.</li><li>Ability to work collaboratively with operations, engineering, and validation stakeholders.</li><li>Sound judgment and decision-making under pressure in a dynamic manufacturing environment.</li><li>Commitment to data integrity, continuous improvement, and patient safety.</li></ul>

Responsibilities: <ul><li>Take full ownership of one or more New Product Development (NPD) projects.</li><li>Lead core teams toward achieving common project objectives.</li><li>Manage project resources effectively to ensure projects are “staffed for success.”</li><li>Collaborate and negotiate with functional managers and the Project Approval Committee (PAC) to address and resolve resource constraints.</li><li>Ensure adherence to the defined product development process and maintain project discipline.</li><li>Keep the team focused on priorities and individual responsibilities.</li><li>Present regular project status updates to the PAC following the contract date.</li><li>Proactively identify risks and drive timely actions to maintain project momentum.</li><li>Resolve conflicts and manage controversial issues constructively.</li></ul>&nbsp;Requirements: Qualifications &amp; Experience <ul><li>Education: Bachelor’s degree required.</li><li>Experience: 5–10 years of experience in project management or a related field.</li><li>Industry Experience: Manufacturing experience is required.</li><li>Proven leadership skills in developing and managing cross-functional teams.</li><li>Demonstrated ability to create effective project plans, manage risks, and handle uncertainties.</li><li>Solid understanding of project management techniques, tools, and best practices.</li><li>Knowledge of manufacturing processes and operations.</li><li>Experience working in a matrix organization and navigating cross-functional dynamics.</li><li>Expertise in balancing time-to-market goals with quality commitments.</li><li>Strong critical thinking, problem-solving, and decision-making skills.</li><li>Excellent verbal communication skills (English proficiency required).</li><li>Certifications: Qualification in Project Management or equivalent; PMP certification preferred.</li></ul>

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>At our client, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.&nbsp;</li><li>Drives the implementation of programs and projects to improve products and processes and develops deployment plans.&nbsp;</li><li>Digital Factory transformation project followed APAC and Internal plant.direction.&nbsp;</li><li>Daily trouble shooting in production, provide short term &amp; long term solution to team.&nbsp;</li><li>Suggest &amp; drive improvements digital solution.&nbsp;</li><li>Support project assignment.&nbsp;</li></ul> Requirements:&nbsp; <ul><li>Plant digitals, cooperate with APAC and our client service team for transformation project.&nbsp;</li><li>Digital factory transformation project implementation, Identify and resolve issue during implementation.&nbsp;</li><li>Training on new digital tools and technologies. Develop training material and provide training to ensure fully utilization.&nbsp;</li><li>Maintain and troubleshooting for exiting digital tools, AGV, Material Calling System, Hydra, dPIM etc.&nbsp;</li><li>Continuous Improvement, identify new opportunities and innovation in operation processes.&nbsp;</li><li>Data analysis and monitoring, Operations Scorecard, Operation Dashboard (SCCOP, SHE, OEE) and advise weakness areas for improvement.&nbsp;</li><li>Handle on CER related /CI working with operations and cross functional team.&nbsp;</li><li>Support operations project assignment.&nbsp;</li></ul> What your background should look like&nbsp; <ul><li>Bachelor’s Degree in Information Technology, Computer science or related field.&nbsp;</li><li>Strong knowledge and experiences in Digital transformation projects.&nbsp;</li><li>Familiarity with digital tools and technologies used in manufacturing.&nbsp;</li><li>Minimum 3 to 6 years working experience in manufacturing sector.&nbsp;</li><li>Knowledge of in cloud technology, virtualization, mobile application, IOT, SQL Server.&nbsp;</li><li>Reporting Services, Power BI, Tableau.&nbsp;</li><li>Good knowledge in Data Storage, Cloud, Microsoft Power Apps.&nbsp;</li><li>Good knowledge in Dashboard creation, Graphic and User Interface (UI) design.&nbsp;</li><li>New enhancement for new functionality in SAP and Hydra.&nbsp;</li><li>OEE, Utilization analysis skill.&nbsp;</li><li>Knowledge and experiences in Enterprise Resource Planning software – SAP/BOM/Routing will be advantage.&nbsp;</li><li>Logical thinking with Project Management Skill.&nbsp;</li><li>Fluent in English and good communication.&nbsp;</li><li>Interpersonal skills.&nbsp;</li></ul>

Responsibilities: <ul><li>Be part of a diverse and collaborative team consisting of engineers, a product manager and a designer.</li><li>Provide technical direction to the team, detecting technical improvement opportunities and taking action to design and implement them.</li><li>Mentor or coach other engineers to support their growth and bring them along</li><li>Design and develop features, APIs, and fixes to handle our current and future scale.</li><li>Help our customers have a great experience products.</li><li>Be a strong independent contributor.</li><li>Participate in and help improve the team’s agile process.</li><li>Engage with the support team as the last level of escalation for tickets.</li></ul> Requirements: <ul><li>Must have 7+ years of expertise in software development.</li><li>Must have 7+ years of experience with Node.JS/Javascript/Typescript ecosystem</li><li>5+ years of experience in Postgres and Redis.</li><li>Excellent communication and collaboration skills&nbsp;&nbsp;</li><li>Expertise in designing, building and maintaining public or internal APIs with focus on security and performance.</li><li>Solid understanding of the Node.JS/Javascript/Typescript ecosystem</li><li>A bias for well tested code and relevant unit/integration/end to end/performance testing experience</li><li>The drive for designing and building highly reliable, scalable, and secure systems</li><li>A mindset for sharing knowledge and supporting the growth of others around you</li><li>Strong context switching capabilities to be able to contribute to several projects at once, within and beyond the team subdomain</li><li>An owner mentality- you hold yourself accountable and have a relentless commitment to loving your customers</li></ul>

Responsibilities: <ul><li>Build secure, performant, cross-platform applications for both customers and internal company teams.</li><li>Collaborate across teams to solve technical and non-technical challenges.</li><li>Work closely with Product and Design to determine and optimize user experience and information architecture.</li><li>Build new features and maintain existing features by contributing across the full technical stack.</li><li>Debug and resolve production issues and implement fixes for them.</li><li>Be a part of the teams on-call rotations.</li><li>Evaluate new technologies and techniques to improve overall practices.</li></ul> Requirements: <ul><li>Must have 7+ years of expertise in full-stack development.</li><li>Have a passion for learning.</li><li>Have excellent communication and collaboration skills.</li><li>Are customer-obsessed and love helping people.</li><li>Have a good understanding of Javascript and TypeScript.</li></ul>

Responsibilities: <ul><li>Support bulk cable team by tracking quality, compiling reports, assist with DOEs and product qualification</li><li>Organize and facilitate Design Review (DR) and Design Failure Modes &amp; Effects Analysis (DFMEA) reviews.</li><li>Implement quality planning and controls for prototype and/or sample builds.</li><li>Complete measurement system analysis for inspection systems and gages to be utilized for the project.</li><li>Review and analyze samples, quality issues and improvement actions during prototype making and CTAR/Qualification.</li><li>Coordinate sample preparation and certification for product verification and qualification testing.</li><li>Conduct and analyze process capability studies in support of Final Tool Approval (FTAR) for all tools and production lines associated with the project using the Comprehensive Tool Approval Report (CTAR).</li><li>Collaborate with MPDE, monitor process capability/data and oversee ongoing corrective actions as required.</li><li>Collaborate with corporate UL team / UL engineer/PJE/PQE for new certification. -Collaborate with PDE, analyze physical/SI data and make qualification report.</li><li>Collaborate with PDE, CA PDE/SI/MPDE, support SQE on outsourced cable quality control and improvement from bulk cable engineering side.</li><li>Preparation for prototype/sample making: -Organize and facilitate Design Review (DR) and Design Failure Modes &amp; Effects Analysis (DFMEA) reviews.</li><li>Complete measurement system analysis for inspection systems and gages to be utilized for the project.</li><li>Data Analysis:Monitor process physical/SI data.</li><li>Review and analyze samples, quality issues and improvement actions during prototype making and CTAR/Qualification.</li><li>Review 108 and finish 501 documents per customer requirement and industrial standards.</li><li>Coordinator during prototype/sample making: -Monitor process capability and oversee ongoing corrective actions as required.</li><li>Support MPDE on FACA.</li><li>Support PDE on design improvement.</li><li>Coordinator during outsourced cable qualification process:Review outsourced cable Physical data, SI data, Reliability data, stability data, give comments from bulk cable engineering side on supplier quality and product quality.</li></ul> Requirements:﻿ <ul><li>Bachelors or Masters Degree in science or technology.</li><li>10 years min. working experience in bulk cable design or manufacturing.</li><li>3 years team management experience.</li><li>Familiar with bulk cable knowledge, bulk cable manufacturing knowledge and machines knowledge.</li><li>Can work under the pressure.</li><li>Drive for results, good problem solving skills</li><li>Good communication skill, integrity, accountability and passion, Integrity, ccountability, team work</li><li>Good communication, interpersonal and management skills</li></ul>

Role Description: <ul><li>We are seeking a talented Mechanical Engineer to join our team in the food manufacturing industry.</li><li>The successful candidate will be responsible for designing, developing, and maintaining mechanical systems and equipment to ensure efficient and reliable production processes.</li></ul> Responsibilities: <ul><li>Conduct feasibility studies and cost analyses for new projects and equipment upgrades.</li><li>Oversee the installation, commissioning, and testing of new mechanical equipment and systems.</li><li>Troubleshoot and resolve mechanical issues to minimize downtime and ensure continuous operation.</li><li>Develop and implement preventive maintenance programs to extend the lifespan of equipment and reduce the risk of breakdowns.</li><li>Collaborate with cross-functional teams, including production, quality control, and safety, to ensure reliable operations.</li><li>Maintain accurate records of engineering activities, including design specifications, maintenance logs, and equipment status.</li><li>Provide technical support and training to maintenance and production staff.</li><li>Evaluate production line postures to develop strategies aimed at minimizing unplanned downtime, enhancing Mean Time Between Failures (MTBF), and reducing Mean Time To Repair (MTTR).</li><li>Led Natural Resources Conservation (NRC) initiatives to enhance sustainability within the plant.</li><li>Direct the implementation of Working Standards within the team’s capabilities</li></ul> Requirements: <ul><li>Engineering degree.</li><li>Minimum 1 year to maximum 4 years of work experience required.</li><li>Preferred Industry--FMCG, Manufacturing</li><li>Team Management experience is preferred but not mandatory to have.</li></ul>

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123 validation engineer Jobs found

Quality Engineer

Senior Project Manager Engineer

QC Chemist

Senior Microbiology Technician

Microbiology Technician

Digital Factory Engineer

Staff Software Engineer(Enterprise)

Staff Software Engineer (Auth0)

Staff Quality & Reliability Engineer

Mechanical Engineer

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123 validation engineer Jobs found

Quality Engineer

Senior Project Manager Engineer

QC Chemist

Senior Microbiology Technician

Microbiology Technician

Digital Factory Engineer

Staff Software Engineer(Enterprise)

Staff Software Engineer (Auth0)

Staff Quality & Reliability Engineer

Mechanical Engineer

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

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