Contract position: A Vaccine Manufacturing Support Engineer is needed for a top 15 pharmaceutical company in the world in the Cambridge, MA area. This role will execute plans for manufacturing and quality system implementation. No per diem available. Responsibilities for the Manufacturing Engineer
Requirements for the Manufacturing Engineer
- Responsible for writing technical assessments to support deviations, change control or certifications. Supports relevant regulatory submission sections for new processes, and/or changes to existing processes for various geographies.
- Identifies and implements system improvements in vaccine operations to improve process performance, manufacturing efficiency and/or operations quality performance. Monitors metrics to assess performance of manufacturing and quality systems and to identify opportunities for improvement.
- Supports risk assessment for raw material and component usage for all vaccines. Helps to identify risks and develops and implement plans to mitigate key risks. Monitors performance of critical raw materials and components and to identify opportunities for improvement.
- B.S. in Engineering, Technology or Science field with at least 5 years of experience in bio- pharmaceutical manufacturing.
- 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).
- Understanding and working knowledge of ERP systems (ie. SAP), preferred but not necessary. Experience with audit inspections and the preparation of responses to regulatory submission questions from agencies is a plus.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.