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CQV PQ Engineer

  1. North America, United States
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
36360
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CQV PQ Engineer - North Carolina - 6 Months Rolling Contract 

Our client, a global pharmaceutical manufacturing organization are looking for a talented CQV PQ Engineer 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.

Essential Duties and Responsibilities for this role include, but are not limited to:
  • Plan and execute Process Qualification (PQ) activities for manufacturing processes to meet cGMP (current Good Manufacturing Practices) and regulatory requirements.
  • Lead the validation of downstream processes, including aseptic filling, purification, and formulation processes.
  • Conduct testing and evaluation of critical parameters such as temperature, pressure, and flow rates to ensure process consistency and reliability.
  • Oversee and manage stability holds during qualification and validation activities to ensure product integrity over time.
  • Collaborate with the stability team to implement testing schedules, analyze data, and ensure that the product maintains its required specifications throughout the stability period.
  • Ensure proper documentation and reporting of stability test results for regulatory submission.
  • Manage microbial holds to ensure microbial control during process validation and qualification activities.
  • Support microbiological testing and sterility assurance programs to validate aseptic processes.
  • Collaborate with the Microbiology and Quality Control teams to ensure microbial risk assessments are properly conducted and corrective actions are taken if necessary.
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.
  • Strong understanding of aseptic processing techniques, sterilization methods, and containment strategies.
If you are interested, please apply now for immediate consideration and further information.
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