Change Control Specialist
We are seeking a skilled professional to oversee process changes, ensuring compliance and efficiency in our manufacturing operations.
* Support vaccine drug substance and/or drug product processes to ensure regulatory requirements are met.
* Collaborate with cross-functional teams to drive successful commercial manufacture and meet organizational goals.
* Develop and implement process change control documentation, technical communications, and risk management strategies.
* Provide technical oversight and planning support for complex partnership models.
* Assess viability of technology in proposed process configurations and verify adherence to required standards.
* Lead team efforts to identify and mitigate partner risks, ensuring timely resolution of production issues.
* Review process change requests, deviations, and Master Batch Record changes to ensure technical compliance.
Requirements:
* Bachelor's degree in Engineering or applicable Science is required. An advanced degree is preferred.
* Experience in pharmaceutical manufacturing, engineering, and/or technical support of operations is essential.
* Excellent leadership, collaboration, change management, interpersonal, analytical skills, and engagement as a team player with dependable interpersonal and communication skills.