CQV Specialist: GMP Validation & IOQ Lead

Veg Group; Rockville (MD); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

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. Responsibilities include IOQ execution, 24-hour temperature mapping, and coordination with site CQV Lead and vendors.

The role requires a Bachelor's degree in Engineering, Science, or related field, plus experience with GMP qualification, IOQ, temperature mapping, and documentation.

Qualifikationen

• Bachelor’s degree in Engineering, Science, or a related field.
• Experience with GMP equipment qualification, IOQ execution, temperature mapping, and validation documentation.
• Strong technical writing, coordination, and organizational skills.

Aufgaben

• Prepare, review, revise, and route validation and design documents for approval.
• Execute Installation and Operational Qualification (IOQ) protocols for each freezer using an approved family qualification strategy.
• Perform 24-hour temperature mapping studies and evaluate results against predefined acceptance criteria.
• Complete three executed IOQ packages with integrated summary reports.
• Revise the PQ Summary Report and GMP Validated Systems form.
• Coordinate with the site CQV Lead, system owners, SMEs, and vendors to support qualification oversight, document approvals, and resolution of protocol discrepancies.
• Maintain a change log documenting effort, issues, and decisions; scan and upload completed protocol packages.

Kenntnisse

GMP qualification

IOQ execution

Temperature mapping

Validation docs

Technical writing

Coordination

Organizational skills

Ausbildung

Bachelor’s degree in Engineering/Science

Jobbeschreibung

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. Responsibilities include IOQ execution, 24-hour temperature mapping, and coordination with site CQV Lead and vendors.

The role requires a Bachelor's degree in Engineering, Science, or related field, plus experience with GMP qualification, IOQ, temperature mapping, and documentation.