Lead CSV Engineer Job Description
We are seeking a highly experienced Lead CSV Engineer to join our team on a global capital project. The successful candidate will be responsible for managing the qualification of GxP Computerised Systems involved in the plant expansion and improvement projects.
Main Responsibilities:
1. Design, commissioning, qualification and validation documentation – drafting, reviewing, and approving CSV related elements of documentation as appropriate.
2. Co-ordinate and execute CSV related commissioning, qualification, and validation activities where applicable, including preparing of validation master plans and executing of DQ, FATs, and SATs.
3. Contribute to the scheduling, tracking, reporting, and achieving of project deadlines.
4. Provide input into the core aspects of operations, qualification, and validation SOP's.
5. Attend departmental and team meetings focused on CSV activities.
6. Serve as a CSV representative for internal technical group discussions.
7. Understand and apply industry specific compliance standards / regulations to all commissioning / qualification activities.
8. Conduct and participate in risk assessments, root cause analysis and investigations.
9. Review, approve and sign off protocols, reports, project change controls and deviations.
10. Proactively highlight any issues around compliance.
11. Participate in internal and external audits and inspections where required.
Requirements:
* 10+ years of CSV experience in Pharmaceuticals or Biopharmaceuticals.
* Experience in process automation.
* Understanding and experience in GAMP, GDP AND cGMP environments.
* Experience with ISA S95 and S88 standards.
* Experience of testing GAMP Category 3, 4 & 5 systems.
* Knowledge of CFR 21 Part11.
Benefits:
This role provides a high degree of autonomy to allow the successful candidate to reach their full potential. You will have the opportunity to work with large corporate clients on exciting capital projects and develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.