Lead CSV Engineer 1554
- Cork
- Permanent
- Full-time
- Design, commissioning, qualification and validation documentation - drafting, reviewing, and approving CSV related elements of documentation as appropriate.
- 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.
- Contribute to the scheduling, tracking, reporting, and achieving of project deadlines.
- Provide input into the core aspects of operations, qualification, and validation SOP's.
- Attend departmental and team meetings focused on CSV activities.
- Serve as a CSV representative for internal technical group discussions.
- Understand and apply industry specific compliance standards / regulations to all commissioning / qualification activities.
- Conduct and participate in risk assessments, root cause analysis and investigations.
- Review, approve and sign off protocols, reports, project change controls and deviations.
- Proactively highlight any issues around compliance.
- Participate in internal and external audits and inspections where required.
- Work closely with the Client QA department and adhere to their requirements.
- Degree level qualification in Science, Engineering or equivalent.
- 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.
- Solid organisational skills including attention to detail and multitasking skills.
- Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
- Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
- Opportunity to work with large corporate clients on exciting capital projects.