Validation Support Contractor

ProQuality Network

Tampa (FL)

On-site

USD 55,000 - 103,000

Part time

4 days ago
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Job summary

ProQuality Network is currently seeking a Validation Support Contractor in Florida. The role focuses on hands-on C&Q activities within clean rooms and regulated manufacturing environments, including CTUs, incubators, equipment and utilities.

You will develop and execute qualification protocols, review documentation, and ensure traceability across projects. The ideal candidate will perform SAT, IQ/OQ/PQ and SMEPAC activities, collaborate with Engineering, Quality, Manufacturing, Microbiology, and

Qualifications

  • Extensive hands-on C&Q experience in regulated manufacturing environments.
  • Experience executing qualification protocols for CTUs, clean rooms, incubators, equipment, and utilities.
  • Ability to develop and execute validation protocols, reports and traceability documentation.
  • Collaborates with Engineering, Quality, Manufacturing, Microbiology, vendors, and contractors.

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.

Skills

C&Q / CQV Validation
IQ/OQ/PQ
Documentation skills
Fast-paced environment
Team collaboration

Job description

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
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