Job Title: C&Q Engineer – Pharmaceutical/Biotechnology Aseptic

Location: North Carolina (Multiple Client Sites)

Employment Type: Contract Position with ProQuality Network

Summary

ProQuality Network is seeking a highly skilled and detail-oriented Commissioning and Qualification (C&Q) Engineer to support multiple projects at our clients’ state-of-the-art pharmaceutical and biotechnology facilities in North Carolina. This role focuses on the commissioning, qualification, and validation of aseptic manufacturing systems, laboratory instrumentation, equipment, utilities, and facilities.

The ideal candidate will have hands-on experience executing C&Q activities in regulated environments, ensuring the successful startup and compliance of critical systems and supporting equipment. This is a 100% onsite contract opportunity through ProQuality Network.

Key Responsibilities

• Develop, review, and execute C&Q protocols (IQ/OQ/PQ) for a broad range of systems including process equipment, packaging lines, laboratory instrumentation, clean and black utilities, facilities, and automation systems.
• Lead and support the full C&Q lifecycle for aseptic manufacturing and packaging equipment (e.g., blister machines, cartoners, labelers, serialization systems), as well as utilities and critical laboratory assets.
• Ensure adherence to current FDA, EMA, and internal quality and regulatory standards.
• Collaborate cross-functionally with Quality Assurance, Validation, Engineering, Manufacturing Operations, and external vendors.
• Participate in and support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and conduct system walkdowns.
• Perform risk assessments (FMEA, HAZOP) as part of equipment and system qualification strategies.
• Manage validation documentation, ensuring accuracy, compliance, and data integrity.
• Provide technical support during the installation, commissioning, and startup of cleanrooms, aseptic processing systems, utilities, packaging lines, and laboratory equipment.
• Investigate and resolve deviations, support Corrective and Preventive Actions (CAPAs), and assist in change control evaluations.
• Support inspection readiness and contribute to internal and external audit preparations.
• Monitor project timelines and deliverables to ensure project milestones are achieved on schedule.
• Propose and implement continuous improvement initiatives and best practices in C&Q activities.
• Perform additional responsibilities as required to support project or organizational needs.

Preferred Qualifications

• Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, Industrial, or a related discipline).
• 5 to 8 years of proven experience in C&Q within pharmaceutical and/or biotechnology aseptic manufacturing.
• In-depth knowledge of validation principles, cGMPs, and applicable regulatory guidelines.
• Experience with packaging systems, including bottling lines, blister packaging, labeling equipment, serialization/aggregation technologies, and inspection devices.
• Proficiency in C&Q documentation, validation lifecycle practices, and change control processes.
• Strong organizational, problem-solving, and analytical skills.
• Excellent written and verbal communication skills.
• Ability to work collaboratively across diverse technical and operational teams in a fast-paced, regulated setting.

If you meet the qualifications and are based in North Carolina or willing to relocate, we encourage you to apply and join us in supporting critical pharmaceutical and biotechnology projects.