Validation Senior Manager

5 days ago

Singapore WuXi Biologics Full time

Subject Matter Expert in cleaning validation and SIP validation lifecycle, from design requirement analysis to retirement for drug substance and drug product manufacturing. Job Responsibilities Role & Responsibilities General: Serve as SME for Cleaning Validation and SIP Validation for the Singapore facilities for Drug Product and Drug Substance Ensure compliance with appropriate regulatory requirements and WuXi Biologics requirements Develop validation SOPs and C&Q deliverables for project start-up and operation readiness Plan, manage and coordinate C&Q activities with internal and external resources/stakeholders Review C&Q deliverables from equipment suppliers / C&Q service providers, develop C&Q documents if required Attend equipment FAT/training as required Track the C&Q deliverables and ensure adherence to schedule from project to operation readiness Lead resolution of validation variance / issues in a timely and compliant manner Perform lesson learnt to share experiences and implement best practices; Provide training and guidance on SOP and skills to team including vendors Maintain and track qualification status of site through periodic review, re-qualification and continue process verification programs and change control system Serve as Cleaning Validation and SIP Validation SME to support the site in audit/visit by clients and regulatory authorities Manage and coordinate Cleaning Validation and SIP Validation activities, and develop validation plans if necessary for NPI, Improvement Projects and Shutdown Maintain site validation master plan and validation SOPs to maintain consistence of validation strategy with various sites of WuXi Biologics Qualification Education Bachelor degree or above in Engineering or Science discipline. Experience Demonstrated experience in validation or QA related work experience in cGMP environment (8 years as a guide) Demonstrated experience in start-up facilities us preferred. Demonstrated experience working in pharmaceuticals facilities in SG, EU or US. Demonstrated experience in audits by EMA, FDA and other international authorities Demonstrated experience in managing projects and team management is preferred. Familiar with pharmaceutical CIP, COP and SIP processes in drug substance and drug product. Demonstrated experience in VHP decontamination, Steam-In-Place and Depyrogenation processes is preferred. Skills In depth knowledge and experience of regulatory requirements and industry standards; Good understanding of Quality System, EHS. Strong collaboration, self-motivation, communication, problem-solving and technical writing skills Demonstrated knowledge of pharmaceutical technology and processes Seniority level Mid-Senior level Employment type Full-time Job function Other Industries Pharmaceutical Manufacturing #J-18808-Ljbffr

  • Validation Engineer

    1 week ago

    Singapore PSC Biotech Corporation Full time

    Join to apply for the Validation Engineer role at PSC Biotech Corporation . Responsibilities include: Process RQs (SIP, Bulk Sterilization, Autoclave)Warehouse mapping Filtration skids Trending of Results Develop, review, and approve validation lifecycle documents, protocols, and reports in accordance with policies, standards, procedures, and guidelines,...

  • Validation Engineer

    2 days ago

    Singapore PSC Biotech Corporation Full time

    Description Join to apply for the Validation Engineer role at PSC Biotech Corporation . Responsibilities include: Process RQs (SIP, Bulk Sterilization, Autoclave)Warehouse mapping Filtration skids Trending of Results Develop, review, and approve validation lifecycle documents, protocols, and reports in accordance with policies, standards, procedures, and...

  • Validation Engineer

    2 weeks ago

    Singapore PSC Biotech Corporation Full time

    Responsibilities RQ of Utilities (WFI)Process RQs (SIP, Bulk Sterilization, Autoclave)Cleaning validation Warehouse mapping Filtration skids Mixing tank Washer qualification Trending of Results Data mining LIMS queries Develop, review and/or approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards,...

  • Validation Engineer

    5 days ago

    Singapore PSC Biotech Full time

    Boon Lay Way, Singapore | Posted on 04/07/2025Process RQs (SIP, Bulk Sterilization, Autoclave)Warehouse mapping Filtration skids Trending of Results Develop, review, and/or approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures, and guidelines, completed in a timely fashion. Lead project...

  • Validation Engineer

    7 hours ago

    Boon Lay Way, South West, Singapore PSC Biotech Full time $80,000 - $120,000 per year

    RQ of Utilities (WFI)​Process RQs (SIP, Bulk Sterilization,Autoclave)Cleaning validationWarehouse mappingFiltration skidsMixing tankWasher qualificationTrending of ResultsData miningLIMS queriesDevelop, review and/or approve validation lifecycledocument and protocols/reports in accordance with relevant policies, standards,procedures and guidelines, and...

  • Senior Validation Engineer

    7 days ago

    Singapore ILLUMINA SINGAPORE PTE. LTD. Full time

    Position Summary: This individual will work in a dynamic team-oriented environment and has primary responsibility for defining, implementing and maintaining validation for manufacturing processes and systems. As a Sr Validation Engineer, you will have a strong process development or process engineering background and is able to work independently requiring...

  • Senior Validation Analyst

    3 days ago

    Singapore Singapore Exchange Full time

    Entity: Singapore Exchange - Location: Singapore, SG - Job Function: Operations & Technology - Job Type: Contract (HC) - Req ID: 2826 **Job Summary**: **Responsibilities**: **Key Responsibilities**: - Lead validation strategy across Technology and Operations, including SGX subsidiaries, with clear milestones and automation goals. - Leverage data and...

  • Senior Validation Engineer

    2 weeks ago

    Singapore PM Group Full time

    : PM Group is looking to expand the CQV team. This role will be supporting one of our pharmaceutical clients in the field of commissioning, qualification and validation work. : - Generation and execution of validation protocols and reports (including IQs, OQs, PQs, QAPs, etc.). - Working as a seconded PM Group resource in a client-led team. - To lead and/or...

  • Senior Validation Engineer

    5 days ago

    Singapore PM ASIA PROJECT SERVICES PTE. LTD. Full time

    **Responsibilities** - Generation and execution of validation protocols and reports (including IQs, OQs, PQs, QAPs, etc.). - To lead and/or support validation projects and activities on site, as directed and as appropriate. - To prepare validation plans in line with the strategic goals of the client and to manage timely and compliant delivery of the plan. -...

  • Senior/engineer - Ssd Validation

    1 week ago

    Singapore Micron Full time

    **Our vision is to transform how the world uses information to enrich life for all.** Join an inclusive team passionate about one thing: using their expertise in the relentless pursuit of innovation for customers and partners. The solutions we build help make everything from virtual reality experiences to breakthroughs in neural networks possible. We do it...