This role is responsible for implementing, qualifying, and continuously improving GMP-compliant hygiene and contamination control processes on site. The position acts as a technical interface across production and quality functions, leading cleanroom hygiene activities, documentation, deviations, and audits while driving standardization and site-wide compliance.
Main Responsibilities
Ensure the effective implementation and continuous improvement of hygiene standards on site
Act as an interface and key link between all departments involved in contamination control, including Production, QA, Monitoring, Engineering and EHS
Plan, lead and execute hygiene projects in the areas of material transfer, gowning, cleaning, disinfection and cleanroom behavior
Take responsibility for planning, coordinating, and performing Cleanroom Performance Qualifications (PQs) in compliance with GMP and site requirements
Prepare, maintain and update hygiene-related documentation in accordance with GMP standards
Investigate deviations within hygiene and environmental monitoring processes, perform root cause analyses, define and track CAPAs
Initiate and own related change requests (CRs)
Manage and execute deviation investigations and ensure timely closure in compliance with quality system requirements
Identify and implement improvement measures to harmonize and standardize hygiene processes across different production areas
Prepare and represent hygiene topics during internal and external audits as well as inspections by authorities and customers
Develop and deliver targeted training programs to strengthen hygiene awareness, and consistent hygiene standards across the site
Qualifications
Degree or vocational education in a scientific discipline such as Chemistry, Pharmaceutical Technology, Pharmacy, Bioprocess Engineering, or equivalent
Professional experience in a GMP-regulated environment, ideally in contamination