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Cleanroom engineer

Anvers
Pauwels Consulting
65 000 € par an
Publiée le 23 avril
Description de l'offre

Our client, a leading pharmaceutical manufacturer, is seeking an experienced engineer to oversee the revamping and upgrade of existing facilities. The role focuses on ensuring HVAC performance and cleanroom compliance within operational GMP environments from design review through to site execution.


Responsibilities

* Review and validate detailed design documentation, technical submittals, and drawings for HVAC systems and classified cleanrooms.
* Monitor daily on-site activities to ensure installation and modification works comply with project specifications and GMP requirements.
* Supervise the installation of HEPA filtration systems, air handling units (AHUs), and pressure cascade implementation.
* Manage site deviations, non-conformities, punch lists, and corrective actions in brownfield environments.
* Coordinate with contractors and CQV teams to ensure proper airflow patterns, balancing, and environmental control.
* Support pre-commissioning walkdowns and verify system readiness prior to official testing.
* Ensure strict adherence to EU GMP Annex 1 and ISO 14644 standards during all revamping and integration works.


Requirements

* You have 5+ years of experience with HVAC systems specifically within pharmaceutical cleanroom environments.
* You bring a strong background in revamping or brownfield projects within operational manufacturing sites.
* You possess a deep understanding of EU GMP Annex 1, ISO 14644, and hygienic design principles.
* You have experience supporting commissioning and qualification phases including HEPA filter leak testing and cleanroom classification.
* You're a proactive, hands‑on problem solver with strong on‑site coordination and contractor supervision skills.


Nice to Haves

* Knowledge of airflow balancing and pressure cascade verification techniques.
* Familiarity with environmental control strategies for temperature and humidity in sterile areas.
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