Computer System Validation (CSV) Engineer

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.