MSAT Cleaning Expert(m/w/x)

Description

You will ensure the highest quality standards by managing complex cleaning validation activities and technical assessments, serving as a key expert during critical inspections and audits.

Requirements

• •Master’s or PhD degree in biotechnology, life sciences, or related disciplines
• •Working experience in biopharma cleaning or cleaning validation
• •Experience in cGMP-regulated biopharmaceutical environment
• •Understanding of biologics manufacturing and cleaning regulatory requirements
• •Proven experience in managing complex projects
• •Ability to manage multiple tasks and meet deadlines
• •Exposure to process development or manufacturing (advantageous)
• •Experience engaging with regulatory agencies (advantageous)
• •Excellent communication, technical writing, and stakeholder management skills
• •Fluency in English; German is an advantage
• •Ability to work on site in Visp 60% of the time

Tasks

• •Develop and coordinate equipment cleaning activities
• •Collaborate with operations, QA, and QC teams
• •Implement validated cleaning methods in routine manufacturing
• •Prepare and organize project-specific cleaning documentation
• •Conduct technical assessments of carryover for cleaning
• •Review and approve buffer cleaning validation reports
• •Manage clean and dirty hold time documentation
• •Perform annual cleaning reviews of the facility
• •Coordinate troubleshooting and support deviation investigations
• •Approve non-conformity records and change requests
• •Serve as the primary counterpart for validation experts
• •Represent the facility as a cleaning SME during audits

Tools & Technologies