Pharmaceutical Operations Specialist
We are seeking a highly skilled Pharmaceutical Operations Specialist to join our team. This exciting opportunity is ideal for those looking to contribute to the success of a leading multinational organization.
Duties and Responsibilities:
* Provide technical support for vaccine drug substance and/or drug product processes to meet European Pharmacopoeia standards.
* Support Water Runs, Equipment shakedown runs, Engineering Runs, and Process Performance Qualification (PPQ) within the manufacturing facility.
* Collaborate across multiple technical functions within the organization and 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.
* Guide External Partners on technology viability in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound.
* Lead team for identification and assessment of partner risks and develop mitigation plans.
* Provide manufacturing process support to External Partner(s) to resolve production issues and offer guidance on process and capacity optimization.
* Coordinate investigations, interface with other impacted manufacturing sites as needed.
* Review External Partner process change requests, deviations, and Master Batch Record changes from a technical standpoint.
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 essential.
* Excellent leadership, collaboration, change management, interpersonal, analytical skills, and engagement as a team player with dependable interpersonal and communication skills (both verbal and written) are required.
Benefits:
This role offers a unique opportunity to work with a dynamic team and contribute to the success of a leading multinational organization.