MSAT Microbial Process Validation Specialist

ppbKPC International - Excellence from Concept to Completion /b /p pbKPC International began operations in 2001. Our team of engineers and scientists has helped our clients achieve project success across the globe within the pharmaceutical and biopharmaceutical industry. /b /p pbWe specialise in Plant Facility Start-Up, from Strategy and Planning through to Execution and Operational Readiness. We are proud to support our clients in delivering life-changing therapies to patients. /b /p h3MSAT Microbial Process Validation Specialist /h3 pWe are looking for an experienced MSAT Microbial Process Validation Specialist to join a leading biopharmaceutical manufacturing environment in Visp, Switzerland /p pThis is an excellent opportunity for a validation professional with strong scientific expertise in microbial or biopharmaceutical manufacturing who can combine technical depth, regulatory knowledge, and cross-functional leadership to support the lifecycle of validated manufacturing processes. /p pThe role as an MSAT Microbial Process Validation Specialist, you will provide scientific and regulatory expertise for process validation activities across biopharmaceutical manufacturing. You will define validation strategies, design and execute validation studies, and author and review validation protocols and reports in accordance with Validation Master Plans (VMPs), SOPs, GMP requirements, and global regulatory expectations. /p pA key part of the position will also be developing and maintaining Continued Process Verification (CPV) programs and supporting Product Quality Reviews (PQRs) to ensure robust ongoing process oversight and lifecycle management. /p h3KEY RESPONSIBILITIES /h3 ul liDevelop and implement process validation strategies, including study designs, protocols, assessments, and final reports. /li liSupport RD and process development teams during process characterization and subsequent validation activities. /li liReview and approve process characterization documentation for scientific robustness and regulatory compliance. /li liPerform validation assessments associated with process changes and deviations and support approval of relevant change and deviation documentation. /li liDevelop, implement, and maintain Continued Process Verification (CPV) plans and ongoing process monitoring strategies. /li liAssess and approve Product Quality Reviews (PQRs) in accordance with applicable quality standards. /li liLead or participate in cross-functional risk assessments to establish appropriate validation and study scope. /li liEvaluate validation data against predefined protocol acceptance criteria. /li liSupport investigations of validation deviations and the definition of appropriate corrective and preventive measures /li liAct as a process validation subject-matter expert during customer audits and Health Authority inspections. /li liCollaborate closely with QA Operations to support batch release activities for processes undergoing validation. /li liSupport validation training programs and mentor junior MSAT validation professionals. /li liDrive effective collaboration across MSAT, QA Validation, Cleaning Validation, QA Qualification, RD, and other key stakeholders. /li /ul h3QUALIFICATIONS AND EXPERIENCE /h3 pBachelor's or Master's degree in Biology, Cell Biology, Biotechnology, Biochemical Engineering, Microbiology, or another relevant Life Sciences discipline. A PhD is advantageous. /p pApproximately 5-10 years of relevant experience across areas such as: /p ul liBiopharmaceutical or microbial manufacturing /li liMSAT / Manufacturing Science Technology environments /li /ul h3You should have strong working knowledge of: /h3 ul liProcess Validation Lifecycle principles /li liContinued Process Verification(CPV) /li liProduct Quality Reviews(PQRs) /li liRegulatory expectations for biologics and microbial manufacturing processes /li liValidation-related deviations, changes, investigations, and risk assessments /li /ul h3Languages /h3 pEnglish: Business fluency, written and spoken /p pGerman: Advantageous but not essential /p h3Why Join KPC Intern /h3 pJoin a growing international team supporting some of the world's leading pharmaceutical and biotechnology companies. You'll have the opportunity to work on major global capital projects while developing your technical expertise across commissioning, qualification and validation act /p pivities.KPC International offers an inclusive environment where you can broaden your experience, work alongside industry experts, and contribute to the successful delivery of life-changing medicines /p pKPC International is an Equal Opportunity Employer /p /p #J-18808-Ljbffr