CSV Engineer – Waterford

KPC International - Excellence from Concept to CompletionCSV Engineer – Waterford

KPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space.

We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life changing products to patients.

We are looking for CSV Engineer who will ensuring the ongoing validation compliance of computerised equipment and systems.

The project based in Waterford and is 12 month’s contract. Initially 100% onsite, after the first few months, up to two days per week remote working may be possible.

Main Duties Will Include

• Integrally involved in the validation of all new computerised equipment, and control systems.
• Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerised equipment and systems.
• Participates in the change control process advising on CSV issues, as appropriate.

Compliance Related Tasks

• Hands on role in the development and execution of DQ, IQ, OQ and PQ activities.
• Ensures projects are managed in compliance with all requirements (Health & Safety, cGMP, construction, environmental etc).
• Designs, implements and executes validation studies for manufacturing and control equipment. Additional responsibilities for critical systems and facilities as well as validation studies to satisfy regulatory compliance.
• Ensure that the validation status of equipment and systems are in compliance with cGMP at all times.
• Maintain validation documentation through the approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans
• Generate/review/approve execution of the validation/revalidation plans
• Review and approval of site change controls
• Ensure compliance to cGMP at all times.

Essential Skills / Qualifications

• Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec)
• 3-5 years experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
• 2-3 years experience in validation environment
• Project management experience.
• Capable of troubleshooting validation issues associated with projects, process development etc.
• Knowledge of requirements for of GAMP, ISPE Baseline guides.
• Full understanding of relevant quality and compliance regulations
• Able to execute projects to plan.
• Good knowledge of quality management systems.
• Good communication skills at organisation, team and individual levels.
• Understands KPI’s for the site.

KPC International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others.KPC – International is an Equal Opportunity Employer.