CQV Specialist – QC Freezer Qualification

Pinnaql, Inc.; Rockville (MD); On-site; USD 90,000 - 140,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Technical writing

Coordination

Organizational skills

Education

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

Job description

Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

We are 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:

• 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.

At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.