Job Title: Sr. Commissioning & Qualification (C&Q) Specialist

Location: North Carolina, USA

Work Type: 100% Onsite (Preference for local North Carolina candidates)

Employment Type: Contract Position with ProQuality Network

Industry: Regulated Industry

Job Summary

Our client is seeking a Sr. Commissioning & Qualification (C&Q) Specialist to support a large-scale laboratory equipment lifecycle and qualification project at a large molecule expansion site in North Carolina. This role is ideal for professionals with strong experience in equipment qualification, project coordination, and regulatory compliance within a regulated environment.

The selected candidate will work with cross-functional teams to manage equipment receipt, qualification, documentation, and lifecycle activities for laboratory instruments and systems as part of a major facility expansion. This position requires hands-on experience in commissioning and qualification, knowledge of laboratory equipment, and familiarity with EU Annex 11 and 21 CFR Part 11 requirements. Preference will be given to candidates located in North Carolina.

Key Responsibilities

Qualification Documentation & Execution

• Qualify laboratory equipment for a large molecule expansion site, including in-place and out-of-place (OOP) qualification activities in accordance with our client’s qualification classes, procedures, and project timelines.
• Prepare required qualification documentation in Kneat, including Annex 11, Part 11, and EHS assessments; URS; qualification protocols; and qualification reports in alignment with our client’s AIQ categories.
• Perform or oversee qualification activities in accordance with our client’s AIQ classifications and vendor-provided qualification packages.
• Prepare protocols and execute IOQ activities.
• Coordinate deviation execution and resolution, as applicable.
• Route qualification documentation for our client’s review and approval.
• Ensure all qualification activities comply with documentation, quality, and regulatory standards.

Out of Scope:

AIQ assessments; calibration and preventive maintenance (PM) activities; supplier assessments; Validation Master Plan; change controls; FAT/SAT; periodic review plans; FS/DS documents; and SOP/WI/logbook creation (refer to Appendix 1 for details).

Execution of Out-of-Place (OOP) Testing for AIQ Equipment

• Coordinate movement of selected equipment from storage to designated OOP testing areas.
• Unpack, inspect, execute OOP testing (or oversee vendor execution), re-pack, and return equipment to storage with complete documentation.

In-Place Qualification for Movable and Fixed Equipment

• Perform full qualification or provide vendor oversight for movable equipment, including activities following OOP testing.
• Perform full qualification or provide vendor oversight for fixed equipment at its final installed location.

Interested candidates are encouraged to apply through the job description link and submit an updated resume for immediate consideration.