Senior Consultant Hygiene Projects

Be the driving force behind seamless logistics for a global CMO, where precision and efficiency are key to supporting world-class manufacturing.

Proclinical is seeking a Senior Consultant Hygiene Projects to support contamination control and hygiene standards at a pharmaceutical or biotechnology site. In this role, you will focus on ensuring compliance with GMP regulations, driving continuous improvement in cleanroom practices, and collaborating across departments to maintain high-quality standards. This position requires a proactive approach to managing hygiene-related projects and documentation while fostering awareness and consistency in hygiene practices.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Implement, monitor, and continuously enhance site-wide hygiene standards.
• Act as the key point of contact between departments involved in contamination control, including Production, QA, Monitoring, Engineering, and EHS.
• Plan, lead, and deliver hygiene-related projects covering material transfer, gowning practices, cleaning and disinfection, and cleanroom behaviours.
• Coordinate and execute Cleanroom Performance Qualifications (PQs) in accordance with GMP and site-specific requirements.
• Create, maintain, and update hygiene documentation to ensure ongoing GMP compliance.
• Lead investigations into hygiene and environmental monitoring deviations, performing root cause analysis and defining appropriate corrective and preventive actions (CAPAs).
• Initiate, manage, and support change requests (CRs) linked to hygiene processes and improvements.
• Ensure deviation investigations are completed and closed within quality system timelines.
• Identify opportunities to harmonise and standardise hygiene practices across all production areas.
• Represent hygiene-related topics during internal audits, external inspections, and customer audits.
• Develop and deliver training programmes to improve hygiene awareness and reinforce site standards.

Key Skills and Requirements:

• Background in a scientific discipline such as Chemistry, Pharmaceutical Technology, Pharmacy, Bioprocess Engineering, or equivalent.
• Experience in a GMP-regulated environment, ideally in contamination control, cleanroom hygiene, or quality management.
• Strong knowledge of GMP regulations and experience with GMP documentation, including SOPs, CAPAs, deviations, and change controls.
• Proficiency in English (written and spoken); German skills are advantageous.
• Analytical mindset with a structured and solution-oriented approach.
• Excellent communication and collaboration skills within multidisciplinary teams.
• Independent, committed, and responsible personality with a strong focus on quality.
  

If you are having difficulty in applying or if you have any questions, please contact Olivier Worch at o.worch@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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