Process Engineer

This range is provided by TSR Consulting Services, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$50.00/hr - $52.00/hr

83070

** Please ONLY local candidates to Warren NJ

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.

Our client, a leading pharmaceutical company is hiring a Process Engineer for a 6+ months contracting assignment.

Must have skills:

• Experience in GMP setting and CAR-T cell therapy
• Sponsor and support the change initiatives and the implementation of process improvement initiatives
• Experience in cell therapy/biologic/vaccine manufacturing support, tech transfer, and validation
• Basic knowledge of facility/clean room design, process, equipment, automation, and validation
• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
• Bachelor’s Degree required in Engineering or Related Discipline (advanced degree is preferred)
• 2 or more years of manufacturing support or related experience in the biopharmaceutical industry

Pay: $50-52/hour W2

Responsibilities:

• Responsible for supporting the production of personalized cell therapy products for global clinical trials
• Design and execute test plans and other risk mitigation exercises as part of investigations (e.g. Root cause analysis and CAPAs)
• Basic knowledge of quality by design and risk management
• Basic experience with Operational Excellence and Lean Manufacturing
• Ensure safe and compliant cGMP operations
• Maintain permanent inspection readiness and actively support regulatory inspections
• Interface with regulatory authorities as required to support Manufacturing Operations audits
• Stay current with industry trends and standards (e.g. PDA, ISPE)
• Provide technical input and investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements
• Design and execute test plans and other risk mitigation exercise as part of investigations (e.g. Root cause analysis and CAPAs)
• Support Clinical Production Activities

• Seniority level Associate

• Employment type
  
  Contract

• Job function Other
• Industries Pharmaceutical Manufacturing

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Medical insurance

401(k)

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