Job description
About the Role
We are looking for a Cleaning Specialist to reinforce the MSAT (Manufacturing Science & Technology) Process Validation team within a pharmaceutical/biotech manufacturing environment. You will be responsible for supporting and executing cleaning validation activities, with a strong focus on washing machine validation and the implementation of a new CIP (Clean-In-Place) station.
Responsibilities:
* Act as Cleaning Specialist within the MSAT Process Validation team
* Support the execution of the washing machine validation strategy, including:
o Review and/or preparation of validation protocols and reports
o Coordination and follow-up of validation tests
o Data analysis and documentation of results
* Design and execute the validation strategy for a new CIP station, including:
o Risk assessments and definition of acceptance criteria
o Drafting and reviewing URS, protocols, and reports
o Participation in FAT/SAT, IQ/OQ/PQ as needed
* Ensure compliance of cleaning validation activities with GMP, regulatory requirements, and internal procedures
* Collaborate closely with Manufacturing, QA, Engineering, and MSAT teams to ensure robust and efficient cleaning processes
* Contribute to troubleshooting and continuous improvement of existing cleaning processes and procedures
* Provide technical support and training to operational teams on cleaning and validation topics
Profile:
* 4–6 years of experience in a similar role in the pharmaceutical, biotech, or related regulated industry
* Solid experience in cleaning validation and/or process validation (equipment cleaning, CIP/SIP, washing machines, etc.)
* Good understanding of GMP and regulatory expectations related to cleaning validation
* Experience with validation documentation: risk assessments, protocols, reports, deviations, CAPA
* Previous exposure to MSAT / Process Validation environments is a strong asset
* Knowledge of Manufacturing (MFG) systems and production processes in pharma/biotech
* Knowledge of Catalent systems and ways of working is a strong plus (or similar CDMO environment)
* Strong analytical and problem-solving skills, with attention to detail and documentation quality
* Ability to work on-site in a cross-functional, international environment
* Fluent in French and English (spoken and written)
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.