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.