Job Title: Change Control SME
We are currently recruiting for a highly skilled professional to support the commercial manufacture of pharmaceutical products. This exciting opportunity is perfect for those looking to work in a leading multinational organization that prioritizes innovation and excellence.
* 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 organization 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.
* Lead teams for identification and assessment of partner risks and develop mitigation plans.
* Provide manufacturing process support to external partners to resolve production issues and provide guidance on process and capacity optimization.
* Support/coordinated investigations with interface with other impacted manufacturing sites.
* Perform a technical review of external partner process change requests, deviations, and master batch record changes.
Required Skills and Qualifications:
* A bachelor's degree in engineering or an 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 (both verbal and written) is required.