Contamination Control Program Lead – Leiden, Netherlands. The role reports to the Site Quality Head and focuses on microbiological contamination prevention and hygiene under cGMP and regulatory standards.
Key Responsibilities- Lead and develop contamination control program, including risk assessments and strategies aligned with cGMP, Johnson & Johnson, and regulatory requirements.
- Drive initiatives to reduce contamination risks and improve microbiological hygiene practices.
- Oversee environmental monitoring programs, trend analysis, and microbiological investigations for excursions.
- Design, implement, and deliver microbiology training and contamination control measures (aseptic techniques, cleaning, disinfection, sterilization).
- Collaborate on equipment and facility design, validation, and critical change approvals.
- Review and update quality control documents such as SOPs and work instructions.
- Develop and implement strategies for contamination reduction (hand hygiene, gowning, hygiene practices).
- Ensure microbiological quality standards are met for cleaning, sterilization, filtration, and depyrogenation.
- Advise on aseptic techniques and operator behaviors to minimize cross-contamination.
- Analyze microbiological and particulate trends and support corrective and preventive actions.
- Coordinate with microbiology and contamination control teams and ensure supplier compliance.
- Support regulatory compliance, safety policies, and best practices.
- Collaborate across teams to share best practices and support resource planning.
- Minimum of 10 years GMP experience in microbiology (preferably pharmaceutical or biotech).
- Master’s degree or PhD in Microbiology or a related field.
- Fluent in English (spoken and written).
- Proven leadership experience with teams and projects, operating effectively in a matrix organization.
- Strong understanding of microbiological testing methods, validation, and regulatory compliance.
- Experience working in a highly regulated environment.
- Excellent communication, organizational, and problem-solving skills.
- Ability to work independently and as part of a multidisciplinary team.
- Base pay range: €82,900 – €144,210 per annum, with 8% holiday allowance.
- Annual bonus based on performance.
- Vacation days, parental leave (minimum 12 weeks), bereavement leave, caregiver leave, volunteer leave.
- Well‑being reimbursement and health programs.
- Service anniversary and recognition awards.
- Insurance plans for employees and eligible dependents.
Salarisomschrijving
€82900 - €144210 monthly