Pharmaceutical Technical Expert
1 week ago
We are seeking an experienced Technical Lead to join our team in Cork. This is a fantastic opportunity for a professional who wants to work with a leading multinational organization that excels in its industry.
Job Description
This position involves providing technical support to vaccine drug substance and/or drug product processes, including person-in-plant support within the manufacturing facility.
- Support Water Runs, Equipment shakedown runs, Engineering Runs, and Process Performance Qualification (PPQ).
- Collaborate across multiple technical functions within the organization and the EP team to ensure successful support and commercial manufacture.
- Author process change control documentation, technical communications, and process risk management.
- Provide technical oversight, management, and planning support for complex partnership models.
- Guide External Partners on technology viability in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound.
- Lead teams for identifying and assessing partner risks and develop mitigation plans.
- Offer manufacturing process support to External Partners to resolve production issues and provide guidance on process and capacity optimization.
- Manage investigations, coordinating with other impacted manufacturing sites.
- Review External Partner process change requests, deviations, and Master Batch Record changes.
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