MSAT Associate Principal Scientist

Your tasks:

• Supporting the process and cleaning validation activities in our biopharmaceutical plant and help ensure the highest standards of quality and compliance.
• Support the development of validation strategies (process or cleaning, as defined) for the assigned projects in the mammalian facility
• Prepare/author validation protocols and reports (for process or cleaning, as defined) according to company specific procedure and in compliance with regulatory.
• Reviewing and approving process/cleaning related documents.
• Support stakeholders, as requested, during the execution phase.
• Assess validation data against acceptance criteria and support investigations of deviations (and approve DR)
• Act as a Subject Matter Expert (SME) for non-conformity records and change requests (responsible for the validation assessment and approval).
• Support PQ studies (protocol/report authoring) related to process validation.
• Represent, as requested, the company in customer-facing meetings
• Assist, as requested, in developing programs and Standard Operative Procedures (SOP) to meet industry standards and regulatory requirements
• Act, as requested, as validation SME during inspections by healthcare authorities and customer audits.

Your experience

• Master’s or PhD degree in biotechnology, life sciences, or related disciplines. 
• Working experience in process validation (ideally as well in cleaning validation) within a cGMP-regulated biopharmaceutical environment.
• Proven experience in managing complex projects, ideally in MSAT or Quality.
• Ability to manage multiple tasks and meet deadlines effectively.
• Understanding of upstream and downstream processes (preferably in mammalian manufacturing).
• Exposure to process development, scale-up, and/or manufacturing (preferably mammalian cell culture).
• Experience engaging with regulatory agencies (Swissmedic, FDA, etc.)
• Excellent communication, technical writing, and stakeholder management skills.
• Fluency in English (written and spoken); German is an advantage.