Cleanroom Contamination Control Engineer

Thermo Fisher Scientific

DNA

Eindhoven, Noord-Brabant - Niederlande

Abteilungsleiter / Manager

Experteer Overview

In this role you will safeguard cleanroom environments by implementing robust contamination control strategies and monitoring performance. You will partner with Manufacturing, Quality, Facilities, and Supply Chain to maintain high cleanliness standards and drive continuous improvement. You address environmental excursions, CAPA, and data-driven monitoring to reduce contamination risk. You will help shape cleanroom operations during design changes and expansions, delivering reliable, compliant production. This position offers hands-on engineering oversight with cross-functional impact and a clear quality-focused mission.

Verantwortungsbereiche

Monitor and optimize daily cleanroom operations to ensure compliance with ISO classifications and GMP where applicable
Develop and implement comprehensive contamination control plans and protocols
Analyze environmental monitoring data to identify trends and risks
Lead or contribute to CAPA, deviations, and change controls
Collaborate with Facilities/Engineering on HVAC performance, IQ/OQ/PQ, and cleanroom qualification
Design and improve material and personnel flows to minimize cross-contamination
Provide training on contamination control best practices to cleanroom personnel
Maintain records and prepare reports for management and regulatory bodies
Support continuous improvement initiatives (Lean/Six Sigma) and digital tooling (MES, EMS)

Zentrale Anforderungen

Bachelor in Engineering in Mechanical, Chemical, Industrial, or related field
4+ years of experience in cleanroom operations or contamination control
Experience with ISO cleanroom classifications and environmental monitoring programs
Root cause analysis, CAPA, and change control experience
Knowledge of HVAC systems, pressure cascades, IQ/OQ/PQ
Familiarity with GMP, SOPs, and regulatory compliance
Strong analytical skills and cross-functional collaboration
Ability to train and guide technical personnel

cross-functional collaboration clear communication training and mentoring HVAC systems and cleanroom qualification (IQ/OQ/PQ)environmental monitoring data analysis CAPA and change control processes

Stellenbeschreibung

In this role you will safeguard cleanroom environments by implementing robust contamination control strategies and monitoring performance. Y…

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