Job Opportunity
We seek a seasoned professional to fill the role of Change Control Specialist.
Key Responsibilities:
* 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 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.
* Lead the 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 optimize processes.
* Support/Coordinate/Manage 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 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 dependable interpersonal and communication skills are required.