Job Description:
We're currently recruiting for an exciting opportunity with a leading multinational based in Cork. This is an excellent position for anyone looking to join a top-tier organization.
As a Change Control Specialist, you will be responsible for providing technical support and oversight to ensure the successful support and commercial manufacture of pharmaceutical products.
* Provide technical support of vaccine drug substance and/or drug product processes to ensure compliance with regulatory requirements.
* Support Water Runs, Equipment shakedown runs, Engineering Runs, and Process Performance Qualification (PPQ).
* Collaborate across multiple technical functions within the organization and the team to ensure seamless support and commercial manufacture.
* Author process change control documentation, technical communications, and process risk management.
* Provide technical guidance to partners, assess viability of technology, verify adherence to required standards, and ensure deliverables are technically sound.
* Lead teams for identification and assessment of partner risks and develop mitigation plans.
* Provide manufacturing process support to partners to resolve production issues and provide guidance on process and capacity optimization.
Required Skills and Qualifications:
* 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, and engagement as a team player with dependable interpersonal and communication skills.
Benefits:
This is an excellent opportunity to work with a leading multinational in Cork. If you're interested in this posting, please contact Seán McCarthy for further information.