Technical Expert - Environmental Monitoring (EM) Imp...

About the job

Technical Expert – Environmental Monitoring (EM) Improvement & Harmonization

In this role, you lead the design, alignment, and implementation of a robust Environmental Monitoring (EM) framework within a global GMP-regulated pharmaceutical environment. You ensure EM practices are compliant with current regulatory expectations while remaining operationally feasible across multiple sites.

You will collaborate with QA, QC Microbiology, and Operations teams to harmonize EM processes, drive continuous improvement, and support the implementation of a science- and risk-based contamination control strategy.

What will you do?

• Lead the design and transformation of Environmental Monitoring programs across sites
• Translate regulatory requirements (EU GMP Annex 1, FDA, USP) into practical EM strategies
• Define and optimize sampling strategies, alert/action limits, and data trending approaches
• Ensure EM data integrity and its effective use for decision-making
• Drive harmonization and standardization of EM practices across multiple sites
• Develop and implement the Target Operating Model (TOM) for EM processes
• Lead deployment of new EM frameworks, ensuring smooth transition and business continuity
• Support training, stakeholder engagement, and change management activities
• Structure and manage projects, including timelines, risks, and deliverables
• Facilitate cross-functional workshops and report progress to senior stakeholders

Who are you?

• Master’s degree in Life Sciences, Bioengineering, Pharmacy, or related field
• Minimum 10–15 years of experience in pharmaceutical microbiology or sterility assurance
• Must have strong hands-on experience with Environmental Monitoring in GMP environments
• Must have in-depth knowledge of EU GMP Annex 1, USP <1116> , FDA guidance, and ISO standards
• Experience working in multi-site or global environments
• Must have knowledge of Annex 11 / 21 CFR Part 11 (data integrity systems)
• Experience with cleanroom classification and microbiological control strategies (e.g. ISO 14644, USP <1072>)
• Background in project/program management or PMO structures
• Experience with contamination control strategies and data integrity principles
• Proven ability to lead cross-functional projects or transformation initiatives
• Strong analytical, problem-solving, and decision-making skills
• Excellent communication and stakeholder management abilities
• Fluent in English & French

What we offer

• A strategic role with high impact on global quality and compliance standards
• The opportunity to lead transformation initiatives across multiple sites
• Collaboration with senior stakeholders and multidisciplinary teams
• A competitive salary aligned with your experience