Team Horizon has an exciting new opportunity for an experienced Autoclave and Parts Washer CQV Engineer to join our expanding team, to work in a large-scale Biopharma manufacturing site in Dublin.
The Autoclave and Parts Washer Validation Engineer will execute commissioning and qualification activities in our client’s cGMP Bulk Drug Substance (BDS) manufacturing plant in Dublin, Ireland. The role is a contract position as part of the CQV team and will be a specialist role in the Equipment Prep area.
Participate in a CQV Team with key emphasis on:
- Membership of Combined CQV Team (Equipment Vendor, Craft Contractor, Specialist Thermal Mapping Vendor, Operations and CQV Personnel)
- Planning of Own Activities
- Ownership and Closure of open issues (Punch Items, Non-Conformances etc)
- Experience in System Startup, Commissioning, Functional Testing & Qualification execution of Autoclave and/or Parts Washer systems including safe systems of work
- Experience with load cycle development.
- Accountable for ensuring activities are scheduled, tracked and reported appropriately, and achieving project deadlines
- Planning and execution of all commissioning activities in adherence to site safety procedures.
- Operate in a manner consistent with the site incident and injury free philosophy.
- Generation and review of protocols, reports, project change controls and deviations.
- Proactively highlighting any issues around compliance.
- Willingly accepting challenging assignments
- Proactively keeping up to date with current thinking and best practice
- Technical diploma or Degree in Engineering/Life Sciences or greater preferred.
- Commissioning, qualification and validation experience in Bulk Drug Substance Manufacturing Facility (min 2 – 5 years).
- Experience in using DeltaV automation platform and review/approval of associated documentation preferred.
- Relevant experience as subject matter expert / engineer in a high-tech industry such as Biotech or Pharma, preferable. Experience working on and knowledge of Biopharma unit operations, including start up.
- Strong technical writing and communication skills.
- Must be goal-oriented and able to prioritize and manage tasks.