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