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CQV PQ Engineers

  1. North America, East Coast
North Carolina
  1. Contract
Competitive
  1. Life Sciences
34360
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 CQV PQ Engineers - North Carolina - 6 Months Rolling Contract 

Our client, a global pharmaceutical manufacturing organization are looking for a talented CQV PQ Engineers to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.

Responsibilities: 
  • Plan and execute PQ activities for manufacturing processes to meet cGMP and regulatory requirements.
  • Lead validation of downstream processes, including aseptic filling, purification, and formulation.
  • Test and evaluate critical parameters like temperature, pressure, and flow rates for process consistency.
  • Oversee stability holds during qualification and validation to ensure product integrity.
  • Collaborate with the stability team to implement testing schedules and analyze data.
  • Document and report stability test results for regulatory submission.
  • Manage microbial holds to ensure control during process validation.
  • Support microbiological testing and sterility assurance programs.
  • Collaborate with Microbiology and Quality Control teams for microbial risk assessments.
  • Investigate microbial deviations and provide technical expertise for resolution.
  • Provide expertise in qualifying and validating aseptic filling processes.
  • Conduct risk assessments and control strategies to ensure sterility.
Requirements: 
  • Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field. Master’s degree preferred.
  • Extensive experience in Process Qualification (PQ) within the biopharmaceutical, pharmaceutical, or life sciences industry.
  • Proven experience in managing stability holds, microbial holds, and aseptic filling process validation.
  • Experience with microbial contamination control, sterility assurance, and managing microbial risk.
  • Familiarity with regulatory requirements (FDA, EMA, ICH) and cGMP standards.
  • Hands-on experience with aseptic filling lines, including troubleshooting, qualification, and process monitoring.
  • Proficient in using data analysis tools and validation software.
  • Strong documentation skills and experience with protocol/report writing.
If this role is of interest to you, please apply now! 
 #LI-MC1
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