CSV Engineer
HybridIndianapolis, Indiana, United States
Job Summary
Develop and execute validation strategies for new and existing process automation and computerised systems, ensuring compliance with pharmaceutical industry standards. Support the implementation and validation of DeltaV, Siemens PLC, PI, and other automation platforms by preparing URS, FRS, IQ, OQ, PQ documents and managing change controls. Execute commissioning and qualification test cases to verify system functionality while identifying and resolving validation deviations. Collaborate with IT QA to drive continuous improvement, provide regulatory training, and ensure alignment with 21 CFR Part 11, GAMP 5, and EU Annex 11. Maintain traceability matrices and support internal audits for regulatory licensure with HPRA, EMA, and FDA.
Required Qualifications
- Bachelor's Degree in Engineering, Information Systems, Computer Science or Life Sciences
- Minimum of 5 years' experience as a CSV Engineer in a pharmaceutical environment
- Experience supporting process automation systems and manufacturing technologies from a CSV perspective
- Good knowledge of 21 CFR Part 11, EU Annex 11, GAMP5 and data integrity guidelines
- Hands on experience validating DeltaV and Siemens PLC automated systems
- Excellent Communication and stakeholder management skills
- Ability to work independently while contributing effectively within a team environment
- Eligibility to work in the United States
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