Description
Role – Validation Engineer HVACType - 12 month + contract
Location – Co. Limerick
Summary
One of our key clients, a global leader within pharmaceuticals, is looking for a highly experienced Validation Engineer on HVAC. Responsible for the day-to-day authoring and execution of Validation activities, working with the broader QA Validation and Automation Teams to ensure validation deliverables are completed per schedule.
Key Responsibilities:
- Qualifying the cleanrooms, leveraging “Testing & Balancing” contractor work for the Air Handling Unit
- Completion of Document Preparation and Field Execution activities for the initial Qualification and Validation of the facility.
- Drive User Requirement Spec (URS) and SIA (System Impact Assessment) approval.
- Generate Equipment Qualification Assessments (EQAs) and subsequent IQ, OQ and where necessary PQ and drive approval of same.
- Execute IQ, OQ and where necessary PQ protocols and drive post-approval of same.
- Interface with the client on Commissioning and Process Sciences teams.
- Support the client Management in Project delivery.
Key Requirements:
- Experienced in Document Preparation and execution of protocols (IQ, OQ, PQ (Environmental Phase1, 2))
- Ideally knowledge of ISO-14644
- Ideally background within the Biopharmaceutical environment experience, but Pharmaceutical is sufficient.
- Experience in Document Preparation and Execution of HVAC systems
- Experience in major start-ups where construction, C&Q, PQ may be concurrent activities.