The CSV Engineer / Specialist will support validation activities for GMP-regulated computerized systems across manufacturing, packaging, and laboratory environments.
This is a hands-on role focused on executing CSV lifecycle deliverables in close collaboration with Quality, Engineering, IT, and project teams to ensure regulatory compliance and on-time project delivery.
Key Responsibilities Execute end-to-end CSV lifecycle activities for GMP computerized systems, including MES, DCS, SCADA, and automated equipment Prepare, review, and support approval of validation documentation, including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ, and Validation Reports Apply risk-based validation approaches for new and existing systems in line with GAMP 5 principles Ensure CSV activities comply with c GMP, GAMP 5, EU Annex 11, and 21 CFR Part 11 requirements Partner with project teams to align validation deliverables with project schedules and milestones Participate in validation risk assessments to define appropriate testing scope and strategy Review system specifications, design documentation, installation records, and qualification evidence Support validation activities across manufacturing, packaging, and laboratory computerized systems Raise, track, and support closure of validation deviations, discrepancies, and observations Support investigations and assess data integrity risks during validation and routine operations Perform periodic reviews of computerized systems and support identification of compliance gaps Contribute to the development, review, and maintenance of CSV and qualification SOPs Support regulatory inspections and internal audits as required Collaborate with local and global CSV teams to ensure consistent validation execution Escalate potential quality or compliance risks to senior CSV or Quality leadership Adhere to site EHS and safety procedures during commissioning and validation activities Qualifications & Experience Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related discipline4–7 years' experience in Computer System Validation within a regulated pharmaceutical or biopharmaceutical environment Strong understanding of CSV regulations, industry standards, and quality expectations Hands-on experience validating GAMP Category 3, 4, and 5 systems Proven experience executing validation protocols and managing CSV documentation Working knowledge of EU Annex 11, 21 CFR Part 11, and GAMP guidelines Experience supporting investigations, root cause analysis, and CAPA activities Strong documentation skills with the ability to collaborate effectively across cross-functional teams
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