CQV Specialist - Lead GMP IOQ & Temperature Mapping

Validation & Engineering Group; Rockville (MD); On-site; USD 90,000 - 120,000; Full time

Job summary

Pinnaql is seeking a Commissioning, Qualification, and Validation (CQV) Specialist to support equipment qualification, validation documentation, and project closeout for three new -80 °C QC freezers. The role emphasizes GMP compliance, rigorous documentation, and cross-functional coordination.

Ideal candidates will have a Bachelor’s in Engineering or Science and hands-on experience with IOQ, temperature mapping, and PQ/GMP validation packages.

Qualifications

• Experience with GMP equipment qualification and IOQ execution.
• Ability to prepare and review validation documentation.
• Strong writing, coordination and organizational skills.

Responsibilities

• Prepare, review, revise, and route validation and design documents for approval.
• Execute IOQ protocols for three -80 °C QC freezers using approved qualification strategy.
• Conduct 24-hour temperature mapping and evaluate against acceptance criteria.
• Complete three IOQ packages with integrated summary reports.
• Revise PQ Summary Report and GMP Validated Systems form.
• Coordinate with CQV Lead, system owners and vendors for validation oversight.

Skills

GMP knowledge

IOQ execution

Temperature mapping

Technical writing

Coordination

Education

Bachelor's degree in Engineering/Science

Job description

Pinnaql is seeking a Commissioning, Qualification, and Validation (CQV) Specialist to support equipment qualification, validation documentation, and project closeout for three new -80 °C QC freezers. The role emphasizes GMP compliance, rigorous documentation, and cross-functional coordination.

Ideal candidates will have a Bachelor’s in Engineering or Science and hands-on experience with IOQ, temperature mapping, and PQ/GMP validation packages.