As a specialist in change control, you will have the opportunity to work with a leading pharmaceutical organization based in Cork.
* You will provide technical support for 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 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.
* Provide technical guidance to external partners on proposed process configurations and verify adherence to required standards.
* Lead teams for identification and assessment of partner risks and develop mitigation plans.
* Support investigations with other impacted manufacturing sites.
* Provide a technical review of external partner process change requests, deviations, and Master Batch Record changes.
A degree in engineering or a related science is required. An advanced degree is preferred.
Experience in pharmaceutical manufacturing, engineering, and/or technical support is essential.
Excellent leadership, collaboration, change management, interpersonal, analytical skills are required.