We are currently recruiting for an exciting opportunity in vaccine drug substance and/or drug product processes to ensure compliance with European Pharmacopoeia (EP) standards.
Key Responsibilities
* Provide technical support to guarantee successful commercial manufacture of pharmaceutical products.
* Support Water Runs, Equipment shakedown runs, Engineering Runs, and Process Performance Qualification (PPQ).
* Collaborate across multiple technical functions within the organization and the EP team.
* Author process change control documentation, technical communications, and process risk management plans.
* 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 mitigation plans.
* Provide manufacturing process support to External Partners to resolve production issues and optimize processes.
* Coordinate investigations, including interface with other impacted manufacturing sites.
* Review External Partner process change requests, deviations, and Master Batch Record changes.
About You
* A 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.
* Strong leadership, collaboration, change management, interpersonal, analytical skills, and communication skills are required.