Current jobs related to Senior Csv Quality Assurance Engineer - Singapore - COMBUILDER PTE LTD

  • CSV Engineer

    2 weeks ago

    Singapore ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD. Full time

    Roles & Responsibilities We are seeking a Computer System Validation (CSV) Engineer with around 5 years of relevant experience to support QC and laboratory operations in a regulated GMP environment. The role involves ensuring that computerized systems and laboratory equipment are validated, maintained, and compliant with regulatory standards, while...

  • Senior Csv Engineer

    6 days ago

    Singapore PM Group Full time

    : We have an immediate requirement for 2 **CSV Specialists **to join a highly skilled PM Group team based on a client site. : **Day to day activities include the following**_:_** - Commissioning and Qualification of hardware and associated software to support Utility/Process equipment. This includes PLC & SCADA plus interfaces with networks. - Documentation...

  • CSV Engineer – QC Systems

    2 weeks ago

    Singapore ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD. Full time

    Roles & ResponsibilitiesWe are seeking a Computer System Validation (CSV) Engineer with around 5 years of relevant experience to support QC and laboratory operations in a regulated GMP environment. The role involves ensuring that computerized systems and laboratory equipment are validated, maintained, and compliant with regulatory standards, while supporting...

  • CSV Engineer

    4 days ago

    Singapore Antaes Asia Full time

    Overview Join to apply for the CSV Engineer role at Antaes Asia . 4 days ago Be among the first 25 applicants. Responsibilities Contribute to Life Science projects for Antaes Asia clients. Work with cross-functional teams in providing Quality oversight in computerized system life cycle procedures and ensure compliance with GXP standards and company policies...

  • Senior Computer System Validation

    1 week ago

    Singapore XOT SOLUTIONS PTE. LTD. Full time

    **Roles & Responsibilities** The Senior Computer System Validation (CSV) Engineer will be based in one of clients who is among the top tier pharmaceutical giants. The engineer will provide a wide range of support for GMP Computerized System and Data Integrity Activities at site. **Responsibilities** - Coordinate/manage multiple small and large CSV/Data...

  • Senior Computer System Validation

    4 days ago

    Singapore XOT SOLUTIONS PTE. LTD. Full time

    **Roles & Responsibilities** The Senior Computer System Validation (CSV) Engineer will be based in one of clients who is among the top tier pharmaceutical giants. The engineer will provide a wide range of support for GMP Computerized System and Data Integrity Activities at site. **Responsibilities** - Coordinate/manage multiple small and large CSV/Data...

  • Csv Engineer

    2 weeks ago

    Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time

    At Coalesce Management Consulting, we are a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists. **Position: CSV Engineer** We are currently expanding our team and are looking for a **CSV Engineer**to support...

  • Csv Consultant

    3 hours ago

    Singapore Valiance Partners Full time

    **Responsibilities**: - Provide Computerized System Validation (CSV) / Computerized System Assurance (CSA) consulting services for pharmaceutical and medical device Manufacturing company. - Manage SDLC (system design life cycle) including risk, deviation and change managements (e.g., conduct risk impact or functional assessment(s)) - Ensure Good...

  • CSV Engineer

    4 days ago

    Singapore PSC Biotech Full time $80,000 - $120,000 per year

    Develop and review validation plans, protocols (IQ, OQ, PQ), and reports for computerized systems. Perform risk assessments and impact analysis related to system validation. Ensure compliance with regulatory guidelines such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Collaborate with IT, Quality Assurance, and Manufacturing teams to support system...

  • CSV Engineer

    3 weeks ago

    Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time

    Roles & ResponsibilitiesResponsibilities:Manage Computer System Validation Lifecycle from design to execution phases, Including relevant CSV documentations such as Configuration specification, design review, commissioning documents, and protocols. Work with QA and stakeholders to develop the CSV strategy Responsible for providing CSV documents and...

Senior Csv Quality Assurance Engineer

3 weeks ago

Singapore COMBUILDER PTE LTD Full time

**Responsibilities**:

- Supervise the day-to-day Quality Assurance activities in accordance with approved Project Plans and Policies for fast-paced green field and/or brown field project.
- Develop and execute quality assurance & validation protocols for GMP plant & systems in the areas such as facilities, utilities and equipment, control systems, process and computerized system, ensuring they meet regulatory requirements and compliance with local, EU, UK and FDA GxP regulatory requirements and any other applicable regulations/standards.
- Collaborate with cross-functional teams to ensure system compliance and validation throughout the project lifecycle. Ensure all equipment, facilities, and systems are validated and compliant with regulatory requirements.
- Lead the qualification coordination meeting to ensure correct event sequence in compliance.
- Review and Approve C&Q plans/protocols/report and GxP SOPs/records
- Review validation life-cycle documents during the commissioning, qualification (IQ/OQ) and validation (PQ) phase e.g., pre and post-execution commissioning/ qualification plans and test specifications, validation summary reports & etc.
- Conduct risk assessments and develop mitigation strategies.
- Maintain detailed documentation of validation activities and ensure all records are audit-ready. Ensure that documents are in compliance with quality standards and applicable regulatory requirements.
- Review engineering change control to evaluate the validation/quality impact(s).
- Support in the resolution of validation deviations and approval.

**Requirements**:

- Master or Bachelor degree in an Engineering, Scientific or Technical discipline.
- Minimum 5 years’ experience working predominantly in Engineering Validation department with emphasis on Computer System Validation execution and Validation activities across manufacturing, laboratories and facilities.
- In-depth knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, ER/ES.
- Excellent practical Knowledge of GxP regulations and guidelines with regards to validation and qualification, ensuring compliance with local, EU, UK and FDA GxP regulatory requirements and any other applicable regulations/standards.
- A working knowledge and practical experience with validation protocols, risk assessments, and regulatory compliance.
- Certified or highly skilled in Six Sigma methodology.
- Strong proficiency in SAP and other enterprise systems.
- Familiarity with tools like Trackwise, Kneat, or similar validation/documentation platforms.
- Previous experience supporting both clinical and commercial manufacturing environments is a plus.