ENGINEER
lisen builders pte. ltd.
Key Responsibilities:
- 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.
Qualifications:
- 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.
Vacancy posted 6 days ago
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