The Validation Engineer will prepare the necessary documentation and monitor progress for technical projects across the organization. The incumbent will be a contributor in supporting the execution of the company’s plans and maintaining the company’s position as a knowledge leader in the biopharma industry.
• Validation documentation – drafting, reviewing, and approving Validation documentation.
• Document coordinator support for Project and Sustaining operations at the Company.
• Execute Temperature mapping studies for controlled temperature units and/or manufacturing areas.
• Participate in Validation Risk Assessments to determine the level of testing required for new equipment.
• Support sustaining and project Validation activities across Bulk Drug Substance, Packaging, and Laboratory areas.
• Input into the core aspects of Operations, Qualification, and Validation SOP’s.
• Maintaining hardcopy records in the Document control archive, including reconciliation of the Document tracker.
• Developing a library of softcopy versions of all Validation test documentation.
• Supporting closeout of TrackWise actions for the Validation team.
• Raising, supporting, and resolving validation deviations as they occur.
• Coordinating a Validation dashboard update for site management/leadership.
• Ensure Requalification and Periodic Review activities are completed in a timely manner.
• Provide support in areas of commissioning and qualification of mechanical, process, electrical, automation equipment and systems and performance test protocols.
• Report / present out on project updates as required
• Encourage and sustain a high safety culture and performance within the Validation teams.
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