Our client, a leading Biotech CDMO company located in Visp (Switzerland), are looking for a Manufacturing Operations Cleaning Expert.
This person will oversee and optimize cleaning processes in a GMP-compliant manufacturing environment, ensuring regulatory compliance and operational excellence. This role will manage cleaning documentation, support internal audits, and drive continuous improvements in cleaning operations during the startup phase of a mammalian-based system.
Key Responsibilities:
Cleaning Operations & Documentation: Lead and optimize cleaning processes, ensuring proper documentation (SOPs, Recipes, EBRs) for GMP compliance.
Audit & Compliance: Act as SME during internal/external audits and support risk assessments for cleaning processes.
Training & Expertise: Collaborate with MSAT and QA teams to improve cleaning processes; develop and deliver training for production staff.
Process Improvement: Lead Lean Six Sigma and Kaizen initiatives to optimize cleaning operations.
Production Support: Supervise cleaning activities, troubleshoot issues, and ensure timely completion of cleaning processes.
Cross-Functional Collaboration: Coordinate with Bioprocess Engineers, MSAT, and QA teams for cleaning schedules and continuous improvement.
On-Call Support: Provide on-call assistance during emergency situations and represent the plant in audits/meetings.
Key Skills:
Expertise in GMP regulations and cleaning process compliance.
Strong background in continuous improvement (Lean, Six Sigma).
Project management and cross-functional collaboration experience.
Ability to train and lead teams in GMP-compliant cleaning practices.
Skilled in problem-solving, risk management, and CAPA implementation .
For further information about this position, please apply with your CV
*Please note, only those with the right to work in Switzerland can apply!*
#J-18808-Ljbffr