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.