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.
1. Support Water Runs, Equipment shakedown runs, Engineering Runs, and Process Performance Qualification (PPQ).
2. Collaborate across multiple technical functions within the organization and the EP team to ensure successful support and commercial manufacture.
3. Author process change control documentation, technical communications, and process risk management.
4. Provide technical oversight, management, and planning support for complex partnership models.
5. Guide External Partners on technology viability in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound.
6. Lead teams for identifying and assessing partner risks and develop mitigation plans.
7. Offer manufacturing process support to External Partners to resolve production issues and provide guidance on process and capacity optimization.
8. Manage investigations, coordinating with other impacted manufacturing sites.
9. Review External Partner process change requests, deviations, and Master Batch Record changes.