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C&Q Engineer

Job Title: Commissioning and Qualification (C&Q) Specialist – Pharmaceutical Manufacturing

Location: North Carolina

Employment Type: Contract


ProQuality Network is seeking a highly motivated and detail-oriented C&Q Specialist to join our team and support our client's mission to deliver excellence in pharmaceutical manufacturing.


Job Description:

The Commissioning and Qualification (C&Q) Specialist will play a key role in ensuring that equipment, utilities, and facilities meet regulatory and operational requirements. This position involves writing, reviewing, and executing qualification protocols and reports while working closely with cross-functional teams in a fast-paced environment.


Key Responsibilities:

  • Develop, review, and execute commissioning and qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Ensure compliance with FDA, cGMP, and other applicable regulatory standards during C&Q activities.
  • Conduct system walk-downs, inspections, and testing to confirm system functionality and readiness for use.
  • Identify and resolve discrepancies or non-conformances in qualification activities.
  • Prepare detailed qualification summary reports, including deviations and resolutions.
  • Collaborate with project managers, engineers, and quality assurance teams to ensure seamless execution of C&Q activities.
  • Support risk assessments and validation planning for new and existing systems.
  • Maintain accurate and organized documentation to ensure traceability and compliance.


Qualifications:

  • Bachelor’s degree in Engineering, Life Sciences, or a related field.
  • 3+ years of experience in commissioning and qualification within the pharmaceutical manufacturing industry.
  • Strong knowledge of FDA regulations, cGMP requirements, and industry standards.
  • Proficiency in writing and executing qualification documents and reports.
  • Excellent problem-solving skills and attention to detail.
  • Strong organizational and communication skills.
  • Ability to work independently and as part of a team in a dynamic environment.


Preferred Qualifications:

  • Experience with specific pharmaceutical manufacturing systems or processes (e.g., cleanrooms, HVAC, sterilization, bioreactors).
  • Familiarity with validation lifecycle documentation.



Thank you. We will be in contact soon.

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