We are seeking a Technical Expert to support vaccine drug substance and/or drug product processes in our EP manufacturing facility.
Key Responsibilities
* Provide technical support for equipment operations, including person-in-plant support, water runs, equipment shakedown runs, engineering runs, and process performance qualification (PPQ).
* Collaborate with cross-functional teams to ensure successful commercial manufacture.
* Develop and implement process change control documentation, technical communications, and process risk management.
* Oversee complex partnership models, assessing viability of technology and ensuring adherence to required standards.
* Lead team efforts to identify and assess partner risks, developing mitigation plans.
* Provide manufacturing process support to external partners to resolve production issues and optimize process and capacity.
* Coordinate investigations with impacted manufacturing sites, reviewing process change requests, deviations, and master batch record changes.
Requirements
* Bachelor's degree in Engineering or applicable Science is required; advanced degree is preferred.
* Experience in pharmaceutical manufacturing, engineering, and/or technical support is essential.
* Strong leadership, collaboration, change management, interpersonal, and analytical skills are required.