Senior Technical Advisor Job Summary
This is an exciting opportunity to join a leading multinational in Cork as a Senior Technical Advisor. The successful candidate will have the ability to provide technical support for vaccine drug substance and/or drug product processes, ensuring compliance with regulatory requirements.
* Main Responsibilities:
* Support water runs, equipment shakedown runs, engineering runs, and process performance qualification (PPQ).
* Collaborate across multiple technical functions within the organisation and the EP team to ensure successful 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 the External Partner, assess viability of technology in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound.
* Lead team for identification and assessment of partner risks and develop mitigations plans.
* Provide manufacturing process support to External Partner(s) to resolve production issues and to provide guidance on process and capacity optimization.
* Support/Coordinate/Manage investigations, with appropriate interface with other impacted manufacturing sites.
* Provide a technical review of External Partner process change requests, deviations, and Master Batch Record changes.
Requirements
* A Bachelor's degree in Engineering or applicable Science is required. An advanced degree in Engineering, Science, or Business is preferred.
* Experience in pharmaceutical manufacturing, engineering, and/or technical support of operations is required.
* Excellent leadership, collaboration, change management, interpersonal, analytical skills, collaboration, and engagement as a team player with dependable interpersonal and communication skills is required.