Cleaning Validation Engineer Senior

Akkodis; Eigenbrakel; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Akkodis seeks a Consultant Cleaning Validation Engineer to deliver expertise in cleaning validation, ensuring patient safety and regulatory compliance across operations and projects.

You will define robust cleaning strategies, author validation documents, and support deviations, CAPA, and audit readiness while promoting continuous improvement with cross-functional teams.

Responsabilités

• Define and justify acceptance criteria (MACO, HBEL/PDE, health-based exposure limits).
• Author, review, and support approval of Cleaning Validation documentation (protocols, reports).
• Ensure procedures are kept up to date in line with GMP expectations and regulatory guidelines.
• Actively coach and share knowledge on regulatory evolutions and industry best practices across teams.
• Provide expert support in deviations, investigations, and CAPA, ensuring root-cause-driven solutions.

Description du poste

Consultant Cleaning Validation Engineer

Purpose of the Role

Support the Site Cleaning Validation Expert by delivering recognized expertise in Cleaning Validation to ensure patient safety, regulatory compliance, and sustainable processes across routine operations and project activities.

Key Accountabilities :

1. Cleaning Development & Cleaning Validation

• Contribute to the definition and continuous improvement of robust, science- and risk-based cleaning strategies (worst-case, grouping, bracketing).
• Support the development and optimization of cleaning processes and methods.
• Define and justify acceptance criteria (MACO, HBEL/PDE, health-based exposure limits).
• Author, review, and support approval of Cleaning Validation documentation (protocols, reports).
• Ensure procedures are kept up to date in line with current GMP expectations and regulatory guidelines.
• Actively coach and share knowledge on regulatory evolutions and industry best practices across teams.
• Provide expert support in deviations, investigations, and CAPA, ensuring root-cause-driven and compliant solutions.

2. Alignment & Business Partnering

• Drive harmonization and standardization of practices across business units.
• Facilitate knowledge sharing and lessons learned.
• Contribute to project governance and cross-functional collaboration.
• Support the definition of resource needs and expertise allocation.
• Contribute to budget planning (projects and capability building).

3. Regulatory & Technical Excellence

• Maintain an active regulatory and technological watch.
• Ensure Qualification & Validation practices remain inspection-ready and aligned with global expectations.
• Contribute to the deployment of quality management, continuous improvement, and digitalization initiatives.

4. Audit Readiness & Quality Oversight

• Ensure auditability and data integrity of Cleaning Validation documentation.
• Proactively elevate quality risks impacting product quality and patient safety.

5. Culture & Ways of Working

• Contribute to a trust-based, collaborative, and inclusive work environment.
• Promote teamwork, collaboration, and knowledge sharing.
• Support a continuous improvement culture focused on delivering value to patients.

Key Behaviours & Mindset

• Proactive and solution-oriented, anticipating risks and driving pragmatic outcomes.
• Trusted Cleaning Validation expert, bringing credibility and technical leadership.
• Reliable and accountable, committed to high quality standards.
• Collaborative team player, enabling cross-functional success.
• Humble and knowledge-sharing, empowering teams without seeking authority.
• Respectful of roles and governance, acting as a partner to business units.
• Hands-on and pragmatic, close to operations and reality.

Key Deliverables

• Harmonized, compliant, and inspection-ready cleaning validation strategies.
• High-quality validation documentation.
• Strong support to investigations and continuous improvement.
• Effective knowledge transfer and capability building across teams.