We are seeking a talented Change Control SME to support the commercial manufacture of vaccine drug substance and/or drug product processes. This is an exciting opportunity for a leading professional in technical operations who can work effectively within a pharmaceutical organization based in Cork.
* Provide technical support and person-in-plant expertise for vaccine drug substance and/or drug product processes 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.
* Offer technical oversight, management, and planning support for complex partnership models.
* Provide technical guidance to external partners on proposed process configurations, ensuring adherence to required standards and deliverables are technically sound.
* Lead team identification and assessment of partner risks, developing mitigation plans.
* Provide manufacturing process support to resolve production issues and optimize process capacity.
* Support investigations with interface with other impacted manufacturing sites.
* Review and approve external partner process change requests, deviations, and Master Batch Record changes.
Required skills and qualifications include:
* A Bachelor's degree in Engineering or applicable Science.
* Experience in pharmaceutical manufacturing, engineering, and/or technical support of operations.
* Excellent leadership, collaboration, change management, interpersonal, analytical skills, and communication skills.
If you're interested in this role, please contact Seán McCarthy at +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.