Contamination Control Program Lead

Job Description:

J&J Innovative Medicine is recruiting for a Contamination Control Program Lead reporting to the Site Quality Head Leiden Biotherapeutics and to be based in Leiden (Netherlands).

Job Summary

Key microbiological expert, partnering with site leadership to develop, maintain, and improve contamination prevention and hygiene programs. You will act as the primary subject matter expert, providing pragmatic guidance on contamination risk prevention under cGMP standards.

Key Responsibilities

• Lead contamination control program, risk assessments and strategies in line with cGMP, Johnson & Johnson, and regulatory standards.
• Drive initiatives to reduce contamination risks and enhance microbiological hygiene practices.
• Oversee environmental monitoring programs, trend analysis, and microbiological investigations for excursions.
• Design, implement, and deliver microbiology training and contamination control measures, including aseptic techniques, cleaning, disinfection, and sterilization.
• Collaborate on equipment and facility design, validation, and critical change approvals.
• Review quality control documents such as SOPs and work instructions.
• Innovate strategies for contamination reduction, including hand hygiene, gowning, and 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, supporting corrective and preventative 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.

Requirements:

• Minimum of 10 years GMP experience in microbiology, preferably within the pharmaceutical or biotech industry
• Master’s degree or PhD in Microbiology or a related field
• Fluent in English (spoken and written)
• Proven leadership experience, including leading teams and projects, with demonstrated ability to operate effectively in a matrix organization
• Strong understanding of microbiological testing methods, validation, and regulatory compliance
  

Preferred Skills:

• 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
  

Required Skills:

Contamination Control, Quality Control Systems

Other Preferred Skills:

Data Quality, Developing Others, Leadership, Quality Control (QC), Quality Management Systems (QMS), System Integration, Team Management