QA CSV

Panda International; Geleen; On-site; EUR 65,000 - 90,000; Full time

Job summary

Panda International is seeking a QA Validation Specialist (CSV) for a 6‑month contract onsite in Geleen, Netherlands.

In this documentation-led role you will review IQ/OQ/PQ records, provide QA final sign‑off that equipment is qualified, and coordinate with CSV, QC and engineering during ramp-up.

Requirements include GMP QA experience, ISPE guidelines, 21 CFR CSV knowledge, and strong attention to detail in a paper‑based review environment.

Qualifications

• Must have QA experience in GMP-regulated manufacturing.
• Knowledge of ISPE guidelines and 21 CFR (CSV).
• Experience qualifying non-computerized systems such as TCUs, fridges, freezers, and incubators.
• Ability to work independently in a desk‑based, paper/document review role.

Responsibilities

• Review IQ, OQ, and PQ documentation.
• Provide QA final approval/sign-off confirming equipment is qualified.
• Review validation protocols (review only).
• Support qualification of new equipment, including bioreactors, room expansions, and biosafety cabinets (BSCs).
• Qualify temperature-controlled units (TCUs) such as fridges, freezers, and incubators.
• Engage with deviations and change requests related to CSV/qualification activities.
• Coordinate with engineering, CSV, QC, and facilities teams to resolve issues.

Skills

QA experience

GMP knowledge

ISPE guidelines

21 CFR CSV

Communication

Tools

TrackWise

Kneat

Job description

QA Validation Specialist (CSV) - Contract

Location: Onsite, Geleen, Netherlands

Contract length: 6 months, with strong likelihood of extension or follow-on project work

Start date: As soon as possible - October

Department: Quality Assurance Validation (QAV)

About the Role

Our client, a global biopharmaceutical manufacturing organization, is scaling up production and needs QAV support during the pre-readiness phase. This is a documentation-led role rather than hands‑on execution - you\'ll be reviewing and approving the work of others, providing QA\'s final sign‑off that equipment and systems have reached a qualified state, and coordinating with CSV, QC, and engineering teams as the ramp‑up progresses.

Key Responsibilities

• Review paper and electronic qualification records, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation
• Provide QA\'s final approval/sign‑off confirming equipment has reached a qualified state
• Review validation protocols (review only - no execution)
• Support qualification of new equipment, including bioreactors, room expansions, and biosafety cabinets (BSCs)
• Qualify temperature‑controlled units (TCUs) such as fridges, freezers, and incubators
• Engage with deviations and change requests as they relate to CSV/qualification activities
• Coordinate and collaborate with engineering, CSV, QC, and facilities teams to resolve technical and documentation issues
• Operate independently in a fast‑paced, cross‑functional environment with shifting priorities

Out of scope: execution of engineering/qualification work, the two new cleanroom suites already in progress, and water injection systems.

Candidate Profile - Must-Haves

• Prior QA experience, ideally within a GMP-regulated manufacturing environment (very senior engineering candidates without direct QA background may also be considered)
• Working knowledge of ISPE guidelines and 21 CFR (CSV side)
• Experience qualifying non-computerized systems such as TCUs, fridges, freezers, and incubators
• Comfortable operating in the "gray zone" - able to apply quality judgment pragmatically rather than rigidly, while still holding standards firmly
• Proactive, able to work independently, and adaptable to a workload that can shift quickly between quiet review periods and high‑urgency stretches
• Strong communication and stakeholder‑management skills - confident working cross‑functionally with engineering and operational colleagues
• Not put off by a heavily desk‑based, paper- and document‑review‑focused role

Nice-to-Haves

• Facilities and utilities background (useful, though not critical for this particular ramp‑up; increasingly overlaps with CSV knowledge)
• Experience with TrackWise (deviations, change requests)
• Familiarity with Kneat (not currently used on the CGT side, but a bonus)

Additional Notes

• Junior candidates are welcome to apply - QA experience matters more than seniority
• This is a fast-moving requirement
• Strong performance and fit may lead to extension or follow‑on opportunities as the wider expansion generates ongoing QAV, CSV, QC, and facilities‑related work