CQV Specialist: GMP Validation for -80°C QC Freezers

Pinnaql, Inc.; Rockville (MD); Vor Ort; USD 90.000 - 140.000; Vollzeit

Zusammenfassung

Pinnaql, Inc. is seeking a CQV Specialist to support equipment qualification, validation documentation, and project closeout for three -80 °C QC freezers. You will prepare IOQ protocols, review validation documents, and coordinate with site CQV Lead and vendors to meet regulatory requirements.

This role emphasizes strong technical writing, coordination, and organizational skills while contributing to a compliant, efficient qualification program that supports a fast-moving biopharma environment.

Qualifikationen

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

Aufgaben

• Prepare, review, revise, and route validation and design documents for approval.
• Execute IOQ protocols for each freezer using an approved qualification strategy.
• Conduct 24-hour temperature mapping studies and evaluate results against acceptance criteria.
• Complete three executed IOQ packages with integrated summary reports.
• Revise the PQ Summary Report and GMP Validated Systems form.
• Coordinate with CQV Lead, system owners, SMEs, and vendors for qualification oversight.
• Maintain a change log and upload completed protocol packages.
• Ensure approvals and closeout activities are completed by Feb 2027.

Kenntnisse

Technical writing

Coordination

Organizational skills

Ausbildung

Bachelor’s degree in Engineering, Science, or a related field

Jobbeschreibung

Pinnaql, Inc. is seeking a CQV Specialist to support equipment qualification, validation documentation, and project closeout for three -80 °C QC freezers. You will prepare IOQ protocols, review validation documents, and coordinate with site CQV Lead and vendors to meet regulatory requirements.

This role emphasizes strong technical writing, coordination, and organizational skills while contributing to a compliant, efficient qualification program that supports a fast-moving biopharma environment.