Full Job Description
CQV Specialist - QC Freezer Qualification
We are seeking a Commissioning, Qualification, and Validation (CQV) Specialist to support equipment qualification, validation documentation, and project closeout for three new -80 6C QC freezers.
Responsibilities:
- 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.
- Ensure required approvals and closeout activities are completed by the end of February 2027, following site procedures and applicable regulatory requirements.
Qualifications:
- 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.
