Senior Validation Engineer

Job Title: Lead CQV Consultant – Cleaning & Equipment Qualification

Location: On-site, full expenses covered

Duration: Contract 6-Months - W2 only (No 3rd parties, no 1099 or C2C)

A high-volume pharmaceutical manufacturing site is experiencing a increase in production, creating urgent demand for improved cleaning processes and additional equipment qualification. We are seeking a Lead CQV Consultant to provide tactical bandwidth and technical expertise to ensure compliance, support the disinfectant efficacy study, and complete the equipment qualification (IQ/OQ/PQ) for new cleaning technology.

Key Responsibilities

• Equipment Qualification: Lead and execute Installation/Operational Qualification (IOQ) activities, ensuring all qualification documentation (including RACI callouts) is completed and compliant with regulatory standards.
• Disinfectant Efficacy Study: Drive the study in collaboration with Quality and Engineering teams to validate new disinfectant technology.
• User Requirement Specifications (URS): Define optimal URS for the new system, addressing Part 11 compliance, user groups, process data management, and electronic qualification (ECQ) connectivity.

Process & SOP Development:

• Define daily usage and optimal cleaning process design.
• Structure qualification for various run types.
• Design and execute Performance Qualification (PQ).
• Translate process design into Standard Operating Procedures (SOPs) and document post-qualification SOPs with annotated impacted documents.

Qualifications

• Proven experience in Commissioning, Qualification, and Validation (CQV) within GMP-regulated environments.
• Strong background in cleaning validation and equipment qualification (IQ/OQ/PQ).
• Familiarity with Part 11 compliance and electronic qualification systems.
• Excellent technical writing skills for URS and SOP documentation.
• Ability to lead cross-functional teams and manage multiple stakeholders.