Senior Process Validation Expert(m/w/x)

Beschreibung

In this role, you will focus on ensuring quality and compliance in a biopharmaceutical plant by developing validation strategies, preparing protocols, and supporting process development. Your expertise will be crucial during inspections and in customer interactions.

Anforderungen

• •Master’s or PhD degree in biotechnology, life sciences, or related disciplines
• •Working experience in process 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
• •Strong 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
• •Able to come on site in Visp 60% of the time

Aufgaben

• •Develop process validation strategies for assigned projects
• •Prepare and author process validation protocols and reports
• •Conduct supporting studies, including hold time and resin lifetime assessments
• •Support Process Development teams during process characterization
• •Maintain a detailed continued process verification plan
• •Assess and approve Product Quality Reviews
• •Review and approve process-related documents
• •Evaluate process validation data against acceptance criteria
• •Support investigations of deviations and approve deviation reports
• •Act as a Subject Matter Expert for non-conformity records and change requests
• •Represent Lonza in customer-facing meetings
• •Assist in developing programs and Standard Operating Procedures to meet industry standards
• •Act as process validation SME during inspections and audits