Due to the sustainable increase of activities for one of our clients, we are looking for CSV Senior Engineer (permanent position with our client). The main responsibility and accountability of the CSV (Computer System Validation) Senior Engineer is to perform computer systems validation activities associated with establishing the business processes required to implement, qualify, change and manage a highly automated & integrated large scale bio-production facility.
- Perform validation activities at the site and ensures the approach and execution aligns to the company's expectations. Scope includes IT, Execution Systems, and Laboratory Analytical systems.
- Provide input on improvement of life cycle documentation. Provide input on SOP (Standard Operations Procedures) development.
- Act as a high-level technical resource for implementation of policy in partnership with the quality organization(s) to ensure alignment in approach and desired acceptance criteria.
- Support the implementation and adoption of the global CSV program and remediation. Support data integrity implementation and remediation for systems within CSV program. Participate in continuous improvement efforts related to CSV program.
- Bachelor’s Degree (BS) with as emphasis in Engineering/Sciences or equivalent.
- 7/10 years of experience in CSV and validation
- Experience with DeltaV or MES Syncade systems is a must
- Understanding of regulations governing computer systems and control such as FDA’s 21 CFR Part 11, EMA’s Annex 11, and MHRA’s data integrity guidance
- Understanding of risk based validation executions
- Background in Lifesciences and/or Pharma/Biotech industries (or understanding of bioprocessing and support processes)
- Direct experience with IT and Manufacturing automation systems supporting GMP (Good Manufacturing Practices) manufacturing