Job description
Mission Description
We are seeking a skilled Contamination Control Engineer to join our dynamic team. In this role, you will play a key part in ensuring the microbiological integrity of our manufacturing processes, cleanrooms, and clean utility systems in compliance with industry standards and internal procedures.
You will be responsible for driving contamination control strategies, supporting compliance initiatives, and contributing to continuous improvement across site operations.
Key Responsibilities
Microbial Control of Processes, Cleanrooms & Clean Utilities
* Develop, implement, and maintain monitoring plans for microbial control across processes, cleanrooms, and clean utility systems.
* Define monitoring limits and perform regular trend analysis of microbial data.
* Propose and lead corrective and preventive actions to enhance contamination control performance.
* Author and deliver Performance Qualification (PQ) documentation for clean utility and cleanroom systems.
* Generate periodic reports on microbial trends and present findings to stakeholders.
Deviations & Change Controls
* Lead or coordinate investigations for deviations related to contamination risks in manufacturing, clean utilities, or cleanroom environments.
* Assess the microbiological impact of proposed changes within the change control process.
* Provide expert microbial input during deviation assessments to evaluate product impact.
* Contribute to the development and execution of the overall Contamination Control Strategy for the site.
Transversal & Continuous Improvement Activities
* Serve as the primary point of contact for contamination control expertise
* Participate in and support internal and external audits and inspections.
* Lead and contribute to training and awareness programs on contamination control best practices.
* Support key site projects such as:
o Launch platform for new clinical products
o EFA production ramp-up
o Dupilumab acceleration program
o Other operational excellence initiatives
Requirements
Education & Experience
* Master’s degree (or equivalent) in Pharmaceutical Sciences, Biotechnology, Life Sciences, or a related field.
* Minimum of 4 to 6 years of professional experience in the pharmaceutical or biotech industry, preferably within manufacturing, quality assurance, or microbiology operations.
* Proven experience in contamination control, environmental monitoring, or aseptic processing is highly desirable.
Key Competencies
* Strong understanding of GMP, regulatory guidelines, and contamination control principles.
* Experience with deviation management, root cause analysis, and change control processes.
* Excellent analytical, documentation, and reporting skills.
* Ability to work independently and collaboratively in a cross-functional environment.
* Proficiency in English (written and spoken); knowledge of Dutch or French is a plus.