Cleaning validation Engineer | Life Sciences

Capgemini Engineering; Diegem; Sur place; EUR 60 000 - 80 000; Plein temps

Avantages offerts par ce poste

Access to sports activities

Mentoring programs

Opportunity to work abroad

Support for work-life balance

Résumé du poste

Capgemini Engineering is seeking an experienced QA Cleaning Validation Engineer to join their QA Engineering department at a leading pharmaceutical manufacturing site in Geel, Belgium. You will ensure that cleaning validation activities meet regulatory standards and support multidisciplinary teams in a dynamic environment.

With 5 to 15 years of experience in the pharmaceutical industry, you will review cleaning validation activities and provide expert input on compliance and quality assurance. Fluency in English and Dutch is required.

Qualifications

• 5 to 15 years of experience in the chemical and/or pharmaceutical industry.
• Solid knowledge of cGMP regulations with clear communication skills.
• Experience with digital cleaning recipe systems and document management.

Responsabilités

• Review and approve cleaning validation activities, ensuring cGMP compliance.
• Participate in change controls related to cleaning processes.
• Support projects related to cleaning validation and monitoring.

Connaissances

Cleaning validation

cGMP regulations

Digital cleaning recipe systems

Project management

Fluent English and Dutch

Outils

MES systems

PCS systems

Document management systems

Description du poste

Job Summary

We are looking for an experienced QA Cleaning Validation Engineer to support the QA Engineering department at a leading pharmaceutical manufacturing site in Geel. In this role, you will play a central part in ensuring that all cleaning validation activities meet the highest regulatory and procedural standards, working across multi‑disciplinary teams in a dynamic and compliance‑driven environment.

Responsibilities

• Review and approve cleaning validation activities, including SOPs, trend reports, protocols, and validation/verification reports, ensuring full alignment with cGMP regulations and internal quality standards.
• Participate actively in change controls related to cleaning processes, providing expert input and ensuring all changes are assessed, documented, and implemented in a compliant manner.
• Support and contribute to projects related to cleaning validation, monitoring, and cleaning verification, including the introduction of new or upgraded systems and processes.
• Review and approve digital cleaning recipes within MES and PCS systems, leveraging technical expertise to ensure accuracy, compliance, and operational efficiency.
• Act as a key point of contact within multi‑disciplinary teams, communicating clearly on quality, compliance, and planning status to stakeholders at all levels, and providing guidance on cGMP aspects related to cleaning activities.

Qualifications

• 5 to 15 years of experience in the chemical and/or pharmaceutical industry, with a strong and demonstrable background in cleaning validation and quality assurance.
• Solid knowledge of cGMP regulations and guidelines, with the ability to translate complex technical information into clear, accessible communication for all levels of the organization.
• Experience working with digital cleaning recipe systems within MES and PCS environments, as well as problem report and change request systems (e.g. Comet) and document management systems (e.g. TruVault).
• Collaborative team player, equally comfortable working independently, able to manage multiple projects simultaneously, assess urgency and impact accurately, and thrive in a cross‑functional environment.
• Fluent in both English and Dutch (written and spoken), enabling effective communication across teams and with stakeholders at this Belgian site.

Benefits

• Passion for Sport: Engage in team‑spirit activities ranging from rugby to golf and participate in major sporting events worldwide.
• Mentoring Programs: Access to career‑stage programs from STEM education to career reentry, fostering professional growth and empowerment.
• FlexAbroad: Opportunity to work abroad for up to 45 days in a 12‑month period across 20+ countries.
• Well‑being Hub: Support for work‑life balance, flexible working hours, and network growth to promote overall well‑being.