Validation Specialist

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.

Description:

We are seeking two (2) CQV Specialist to support installation and operational commissioning, engineering documentation, and project closeout for

• Mapping Equipment to be covered by supplier (24 hours study for refrigerator)
• Equipment within scope for qualification and/or documentation:
o One (1) 2-8C Refrigerator unit (relocation not a new unit)[BR1.1][PY1.2]
o One (1) Filter Integrity Tester Device
o Two (2) Tube Welders
o Two (2) Linkit AX (Peristaltic pump, purge stand and digital balance)
o Two (2) ProMixers (drive and connection unit)
o Two (2) PalletTanks (50L, 200L)
o Two (2) Tube Sealers

**Responsibilities:**

- Prepare, review, revise, and route the Commissioning (Cx) Plan, equipment family protocols, and Cx Plan Summary Report for approval.
- Execute installation and operational commissioning protocols using an approved family commissioning strategy.
- Evaluate test results against approved acceptance criteria and prepare executed protocol packages with integrated summary reports.
- Support investigations, risk assessments, and closure of exceptional conditions.
- Coordinate equipment readiness, vendor documentation, reviews, and approvals with the site CQV Lead, system owners, and SMEs.
- Maintain change, risk, and decision logs; provide weekly status updates; and upload finalized commissioning records.
- Complete project closeout by the end of March 2027, following site procedures and applicable regulatory requirements.

Qualifications:

- Bachelor’s degree in Engineering, Science, or a related field.
- CQV Experience - equipment in a GMP environment.
- Strong technical writing, protocol execution, troubleshooting, and coordination 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.