Technical expert – Environmental Monitoring improvement & harmonization
Brabant Wallon – contracting
Your responsibilities?
The primary purpose of this role is to lead the design, alignment, and implementation of a robust Environmental Monitoring (EM) framework, ensuring full compliance with current regulatory expectations while maintaining operational feasibility across multiple sites.
1. Technical Leadership
-
- Lead the design and transformation of the Environmental Monitoring program across sites
- Ensure alignment with current regulatory expectations, including : EU GMP Annex 1 (2022), Contamination Control Strategy (CCS) principles, FDA and relevant ISO standards
- Define and challenge: Sampling strategies (viable and non-viable), Alert and action limits, Data trending methodologies, Investigation approaches for excursions and contamination events
- Provide scientific and risk-based justification for all proposed changes
2. Process & Operating Model Definition
-
- Co-develop the EM process and Target Operating Model (TOM) ensuring:
- Clear roles and responsibilities (QA, QC Micro, Operations)
- Effective governance and decision-making
- Operational feasibility across sites
3. Multi-site Harmonization
-
- Assess differences in EM practices across sites
- Facilitate alignment and define harmonized standards
- Balance standardization with necessary local adaptations
4. Deployment & Implementation
-
- Lead the transition from current to target EM framework, including: Identification of what must be created, adapted, or maintained
- Definition of a pragmatic deployment roadmap
- Ensuring continuity of operations during implementation
- Support adoption through: Training strategy, Stakeholder engagement, Change management actions
Your profile?
-
- Minimum 5-10 years of experience in pharmaceutical microbiology / sterility assurance
- Strong, hands-on experience with Environmental Monitoring programs in GMP environments
- Good understanding of: EU GMP Annex 1 (2022); USP – Microbiological Control and Monitoring of Aseptic Processing Environments; 21 CFR Part 211 and FDA Aseptic Processing Guidance; ISO 14644 (cleanroom classification and control); Contamination Control Strategy (CCS) principles; Data integrity requirements (Annex 11, 21 CFR Part 11); Disinfection and microbiological control strategies (e.g. USP )
- Project & Leadership Capabilities
- Experience leading cross-functional projects or transformation initiatives
- Strong facilitation and stakeholder management skills
- Ability to translate regulatory requirements into practical, operational solutions
- Scientific rigor with pragmatic mindset
- Ability to challenge constructively and influence senior stakeholders
- Strong decision-making capability based on risk and data
- Ability to bridge QA, QC, and Operations
Our offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.