Description
Role – Validation Engineer – Clean UtilitiesType - initially 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 within Clean Utilities. 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:
- Completion of Document Preparation and Field Execution activities for the initial Qualification and Validation of the facility’s utilities.
- Drive User Requirement Spec (URS) and SIA (System Impact Assessment) approval.
- Generate Equipment Qualification Assessments (EQAs) and subsequent IQ, OQ and where necessary PQ. 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:
- Strong background within Qualification/Validation of Clean Utilities within Pharmaceutical/Biopharmaceutical environment.
- Experience in Doc Prep (IQ, OQ, PQ) and execution of Bulk Bio Clean Utilities – WFI Generation, WFI Storage / Distribution, Clean Steam Generation and Distribution, Process Gases (O2, N2, CO2) Distribution
- Working knowledge of qualification risk assessments
- Experience in major start-ups where construction is a strong advantage