Cleaning Validation Engineer
Location: Geel, Belgium
Employment Type: Full-time (40 hours per week)
Work Mode: Onsite
Role Overview
We are looking for a Cleaning Validation Engineer to join the Manufacturing Science and Technology (MSAT) team, with a dedicated focus on cleaning validation within a GMP-regulated API manufacturing environment.
In this role, you will act as a subject matter expert, ensuring compliant, efficient, and timely execution of cleaning validation activities while supporting audits, new equipment introduction, and continuous improvement initiatives.
Key Responsibilities
* Act as a core member of the MSAT team, with primary responsibility for cleaning validation activities.
* Prepare, review, and update cleaning validation documentation, including protocols, reports, and studies.
* Serve as gatekeeper for proposed changes, prioritizing and coordinating required cleaning validation projects.
* Ensure the right-first-time introduction of new products (NPI) and new equipment into the cleaning validation program.
* Provide preparation and active support during internal and external audits.
* Ensure all cleaning validation activities are executed in compliance with GMP and regulatory requirements.
* Report deviations, incidents, and (near) accidents in accordance with site procedures.
* Propose and implement improvements to enhance cGMP compliance and validation efficiency.
Key Competencies
Technical & Professional Expertise
* Strong expertise in API manufacturing processes.
* In-depth knowledge of cleaning validation and validation principles.
* Solid understanding of statistics and data analysis.
* Experience with project management, including planning, organization, coordination, and prioritization.
* Strong Quality & Compliance mindset, with thorough knowledge of cGMP requirements, particularly in the area of cleaning validation.
Personal & Interpersonal Skills
* Ability to manage complex environments, strict timelines, and change.
* Comfortable interacting with multiple levels of the organization.
* Able to work under pressure, handle conflicting priorities, and manage time effectively.
* Strong customer- and business-oriented mindset.
* Proactive communicator who keeps management informed and seeks alignment when technical or stakeholder challenges arise.
* Result-driven personality with strong communication skills.
\ducation & Languages
* Master's degree in (Bio)Sciences, Life Sciences, or a related field.
* Fluent in English; knowledge of Dutch is required or highly preferred.