Description
Role - QA Validation Engineer - Downstream PurificationType - 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 on Downstream Purification equipment. 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.
• Drive User Requirement Spec (URS) and SIA (System Impact Assessment) approval.
• Generate Equipment Qualification Assessments (EQAs) and subsequent IQ, OQ and where necessary PQ, Cleaning Validation protocols; 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 CIP and SIP validation programs as necessary.
• Support the client Management in Project delivery.
Key Requirements:
• Strong background within the Biopharmaceutical environment experience
• Experience in Document Preparation and Execution
• Experience in major start-ups where construction, C&Q, PQ may be concurrent activities.
• Good technical knowledge of equipment and the concepts of BioTech manufacturing.