CSV Engineer: GMP Systems Validation

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 supporting continuous improvement...

**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...

**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...

We are currently expanding our team within our Life Sciences Division team and are looking for a **CSV Engineer**to support projects on site with a client. The following are key responsibilities: - Design, develop, and execute of CSV strategies for DeltaV systems, ensuring alignment with regulatory requirements and project timelines. - Collaborate with...

Our esteemed client is seeking highly qualified and skilled CSV Engineers, both at the Senior and Junior levels, to provide essential support for routine and project-based Computer System Validation (CSV) activities. As a CSV Engineer, you will be instrumental in ensuring the compliance, reliability, and efficiency of computer systems utilized across diverse...

PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors. With offices across Europe, Asia and US, our core focus is on consistently delivering high quality outcomes for our multinational...

As a CSV Engineer, you will be working for our clients in the respect of the applicable regulations and quality procedures. Main assignments: - To be responsible for preparing and/or executing validation activities and documentation for Computerized Systems, under respected regulations or guidelines: 21 CFR Part 11, 21 CFR Part 820, ISO 13485, GAMP 5,...

**Job Responsibilities - As the Subject Matter Expert (SME) in CSV topics, provide guidance and support to establish systems for ensuring Data integrity, compliance to CSV Plan and 21CFR Part 11. - Ensure/ Establish CSV master plans and execution plans for GXP computer systems like DCS, PLC. - Generate, review and execute protocols for initial and periodic...

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...

Key Responsibilities: Develop and review validation plans, protocols (IQ, OQ,PQ), and reports for computerized systems. Perform risk assessments and impact analysis related tosystem validation. Ensure compliance with regulatory guidelines such asFDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Collaborate with IT, Quality Assurance, andManufacturing teams to...