This is a contract job with a pharmaceutical-manufacturing company.

Some hybrid work will be offered
Must have Experience: Upstream experience & cell culture, Pharmaceutical Work Experience, Excel & Power point Experience in Spotfire, JMP or Statistica
Nice to Have: Experience in Automation System: PI Previous GMP Experience

• Develop process design basis, including sizing and selection of equipment, mass balance, URS and instrumentation for control of robust processes.
• Provide input to industrialization strategies and rationale for critical process parameters.
• Responsible for process design and continuous improvements, support execution and documentation of development and/or validation studies and lead or supervise groups and/task force in the planning of engineering, investigational, definition and process validation runs.
• Document and interpret study results with recommendations.
• Provide technical leadership as a subject matter expert in multiple areas of responsibility.
• Document and interpret study results with recommendations.
• Execute life-cycle design and industrialization of upstream processes, products and associated test methods for Phase 3 and licensed products (new vaccines and biopharmaceuticals AND life-cycle improvements) to assure commercialization of robust, compliant, and efficient processes and test methods for vaccines and biopharmaceuticals.
• Input to design space/DOE studies through establishment of scale-up/scale-down parameters utilizing engineering fundamentals (mixing, mas /heat transfer, modeling, dimensionless parameters, etc.) and process control strategies.
• Partner with engineering to ensure industrial implementation of process design, including review of engineering design documents, provide review and input to C&Q strategy and participating in testing of equipment.
• Provide technical assistance to manufacturing and quality operations for process troubleshooting, and health authority inspections to achieving site metrics (+QDCI).
• Expertise in one or more upstream process unit operation design typically used in biotech/vaccine manufacturing (seed expansion, viral growth and egg processes, harvest/clarification) as well as project/engineering lifecycle.

Experience in equipment start-up, qualification and validation is preferred. Bachelor's Degree/Undergraduate Degree or Advanced Degree in chemical or biochemical engineering. Advanced degree in sciences with Large scale process equipment design, scale-up implementation & validation experience

Job Type: Contract

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person
• Manufacturing facility

Ability to commute/relocate:

• Framingham, MA: Reliably commute or planning to relocate before starting work (Required)

Experience:

• GMP: 1 year (Preferred)
• Manufacturing: 1 year (Preferred)

Work Location: One location

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