Validation Support Contractor

Title: Validation Support Contractor

Location: Florida, USA | Work Setting: 100% Onsite

Work Arrangement: Contract through ProQuality Network

Positions Available: 1

Important Notice: This opportunity is open exclusively to direct individual candidates who reside in the state of Florida. Third-party contractor submissions, staffing vendors, and Corp-to-Corp (C2C) arrangements will not be considered for this position.

Summary

Our client is seeking a C&Q Specialist with extensive hands-on experience in Commissioning & Qualification (C&Q) within clean rooms and regulated manufacturing environments. The ideal candidate will have experience executing qualification protocols for CTUs, clean rooms, incubators, equipment, and utilities, while working effectively in a fast-paced environment.

Key Responsibilities

• Execute SAT, IQ/OQ/PQ, SMEPAC, containment, room, equipment, CTU, and utility qualifications.
• Develop and execute validation protocols, reports, and traceability documentation.
• Perform C&Q activities for clean rooms, incubators, CTUs, equipment, and utilities.
• Support projects involving an encapsulator, high-potent suite, misting booth, DHU, iCAPS, BMS, compressed air, and auxiliary equipment.
• Support incubator conversion from walk-in incubator to freezer and qualification of a pharmaceutical filling room and associated utilities for new equipment.
• Perform documentation review, troubleshooting, and SOP support.
• Collaborate with Engineering, Quality, Manufacturing, Microbiology, vendors, and contractors.

Key Skills

• Extensive C&Q / CQV / Validation experience in regulated manufacturing environments.
• Hands-on C&Q experience with clean rooms, CTUs, incubators, equipment, and utilities.
• Strong experience with IQ/OQ/PQ, SAT, SMEPAC, room, equipment, and utility qualification.
• Strong technical documentation and protocol execution skills.
• Ability to work effectively in a fast-paced environment, under pressure, and adapt to changing priorities.
• Local candidates preferred.

Deliverables

• Executed protocols and raw data
• Final qualification reports
• Traceability matrices
• C&Q supporting documentation
• SOP input/development