Biotech·1 month ago
1 month ago
CSV Engineer
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What you'll do
- 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 qualification and validation activities.
- Manage change control and deviation investigations related to validated systems.
- Support audits and inspections by regulatory authorities.
- Maintain validation documentation and ensure traceability throughout the system lifecycle.
What they're looking for
- Bachelor’s degree in Pharmacy, Life Sciences, Engineering, Computer Science, or related field.
- 5-8 years of experience in CSV within pharmaceutical manufacturing or related regulated industries.
- Strong knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP 5 guidelines.
- Experience with validation of PLC SCADA, MES, or other pharma manufacturing Automation systems.
- Excellent documentation and communication skills.
- Ability to work independently and in cross-functional teams.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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 qualification and validation activities. Manage change control and deviation investigations related to validated systems. Support audits and inspections by regulatory authorities. Maintain validation documentation and ensure traceability throughout the system lifecycle. Requirements Bachelor’s degree in Pharmacy, Life Sciences, Engineering, Computer Science, or related field. 5-8 years of experience in CSV within pharmaceutical manufacturing or related regulated industries. Strong knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP 5 guidelines. Experience with validation of PLC SCADA, MES, or other pharma manufacturing Automation systems. Excellent documentation and communication skills. Ability to work independently and in cross-functional teams.
Company
Biotech
Boon Lay Way, Singapore
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