Contamination Control Program Lead

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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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

This role offers an exciting opportunity to impact microbiological quality and contamination control in a dynamic manufacturing environment.

"The anticipated base pay range for this position is 82,900 EUR to 144,210 EUR on an annual basis and includes 8% holiday allowance"

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