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Title: Engineer Vaccine Manufacturing Support
Job Description & Responsibilities
- Support implementation of vaccine manufacturing and quality systems in collaboration with quality, supply chain and information technology staff. These systems include the Quality Management System and systems required for material control and supply planning.
- Provide technical support for raw materials and components (RMC) drug product management. Includes writing or contributing to technical assessments in support of RMC deviation management, change control, comparability assessments, and regulatory submissions.
- Provide life cycle support and continuous improvement of the company's vaccine manufacturing and quality systems. Identifying and implementing continuous improvement opportunities in vaccine operation s use and management of RMC.
- Partner with quality, supply chain, procurement, information technology, operations and product development groups to coordinate timely closure of change controls, deviations and CAPAS related to the external manufacturing.
- Support regulatory section writing and review.
- Write technical assessments to support deviations, change control, or comparability assessments. Supports relevant regulatory submission sections for new processes, and/or changes to existing processes for various geographies.
- Support execution of project plans for diluent contract manufacturers.
- Coordinate risk assessments for raw material and component usage for all vaccines. Help to identify risks and develops and implement plans to mitigate key risks.
Skills, Experiences, Knowledge
- B.S. in Engineering, Technology or Science field with at least 3-5 years of experience in bio- pharmaceutical manufacturing. A degree in biochemical engineering/ biotechnology or related discipline is highly preferred. Specific experience in manufacturing and quality systems or in raw materials and components management is a plus.
- Must demonstrate knowledge of cGMPs, with applied knowledge of bio-pharmaceutical manufacturing (e.g. biological drug substance production or formulation, filling, and finishing of parenteral products).
- Possess demonstrated leadership abilities along with technical writing, problem-solving and project planning skills.
- The candidate must be self-motivated, able to meet project deadlines and budgets. Teamwork and collaboration skills are integral to the position. Demonstrated ability to manage work in cross functional team setting and lead cross-functional team meetings
- Experience with audit inspections and the preparation of responses to regulatory submission questions from agencies is a plus.