Change Control Specialist
We are seeking a skilled Change Control Specialist to join our team. As a key member of the EP manufacturing facility, you will play a critical role in ensuring the successful support and commercial manufacture of vaccine drug substance and/or drug product processes.
* You will provide technical support to EP, including person-in-plant support directly within the EP manufacturing facility.
* 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 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.
* Assess viability of technology in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound.
* Lead teams 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.
* Coordinate investigations with other impacted manufacturing sites.
* Review External Partner process change requests, deviations, and Master Batch Record changes.
Requirements:
* A Bachelor's degree in Engineering or Science is required; an advanced degree is preferred.
* Experience in pharmaceutical manufacturing, engineering, and/or technical support of operations is necessary.
* Excellent leadership, collaboration, change management, interpersonal, analytical skills are required.