Our global client based in Valais is looking for an English speaking Cleanroom PQ to join their team on a long term 12 contract with the future potential to also become a full time employee at the end of the contract. The role is looking to start in the next month.
Develop and execute Performance Qualification protocols for cleanrooms and classified areas (Grade A–D) in accordance with GMP, FDA, EMA, and ISO14644 requirements.
Perform cleanroom airflow visualization studies (smoke studies), particle count testing, HEPA filter integrity testing, and recovery time measurements.
Lead or support cleanroom requalification following maintenance, facility modifications, or scheduled validation cycles.
Collaborate with QA, Engineering, and Operations to ensure proper cleanroom design and functionality align with regulatory expectations.
Prepare comprehensive PQ reports, deviations, CAPAs, and ensure timely documentation in support of regulatory audits and inspections.
Support cleanroom qualification for new facilities or expansions, contributing to project commissioning and validation timelines.
Interface with equipment qualification teams to align HVAC, cleanroom, and critical utility PQ strategies.
Train operators and stakeholders in PQ procedures, aseptic behavior expectations, and environmental monitoring techniques when needed.
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