CQV Specialist – QC Freezer Qualification & IOQ Lead

Validation & Engineering Group, Inc.; Rockville (MD); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Pinnaql, a trusted consulting partner to regulated life sciences companies, seeks a CQV Specialist – QC Freezer Qualification to support equipment qualification, validation documentation, and project closeout for three new -80 °C QC freezers in a GMP-compliant setting.

The ideal candidate has a Bachelor’s degree in Engineering or Science and hands-on experience with IOQ, temperature mapping, and validation deliverables, with strong writing and coordination skills.

Qualifikationen

• Bachelor’s degree in Engineering, Science, or related field.
• Experience with GMP equipment qualification and IOQ execution.
• Experience with 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.
• Ensure required approvals and closeout activities are completed by the end of February 2027, following site procedures and applicable regulatory requirements.

Kenntnisse

Technical writing

Coordination

Organizational skills

Ausbildung

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

Tools

IOQ execution

Temperature mapping

Validation documentation

Jobbeschreibung

Pinnaql, a trusted consulting partner to regulated life sciences companies, seeks a CQV Specialist – QC Freezer Qualification to support equipment qualification, validation documentation, and project closeout for three new -80 °C QC freezers in a GMP-compliant setting.

The ideal candidate has a Bachelor’s degree in Engineering or Science and hands-on experience with IOQ, temperature mapping, and validation deliverables, with strong writing and coordination skills.