PpThis position is located in Stein, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. /p pToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. /p pFor Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Stein and Basel, Switzerland we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment! Join this outstanding team by applying for this senior position as Global MSAT Drug Product Qualification and Validation Lead! /p h3What you’ll get: /h3 ul liAn agile career and a dynamic work culture /li liAn inclusive and ethical workplace /li liCompensation programs that recognize high performance /li /ul h3What you’ll do: /h3 ul liServe as global process owner for DP manufacturing process control strategy including equipment qualification (PQ), process validation (PPQ), and continued process verification (CPV) for liquid (vial/PFS/Cartridges) as well as lyophilized dosage forms for biological products. /li liLead the development and governance of corresponding global SOPs, Standards, Templates, and Tools aligned with regulatory and industry best practices. /li liOwn the equipment qualification (PQ) strategy for key unit operations e.g. DS thawing, compounding, filling, lyophilization, and crimping. /li liSupport customer products throughout the 3 phases of process validation (process design, PPQ and CPV) by providing guidance and oversight to Tech Transfer and local MSAT teams for optimum justification of product specific validation strategies (PPQ and CPV) including scale up activities and statistical support e.g. sampling plan justification. /li liAs required, review and approve process validation documentation; conduct statistical analysis on production data for each phase of process validation. /li liActive participation in health authority inspections as SME for process validation and CPV/OPV strategy, as applicable /li liImplement Process Capability/Quality/Cost Improvement Changes /li liEnable innovation and technical strategy projects associated to DP aseptic manufacturing /li /ul h3What we’re looking for: /h3 ul liPh.D. in pharmaceutical sciences, pharmaceutical engineering, biochemistry, or related fields or equivalent experience /li liProven extensive experience and technical knowledge of equipment qualification related to aseptic drug product manufacturing processes /li liProven Extensive experience of process validation and current validation approaches for sterile manufacturing of biological drug products (lyophilized products, liquid in vials and PFS) including proven experience with regulatory submission with HAs and PAI /li liProfound understanding of statistics; experience with SAA JMP / STATISTICA software is highly desirable /li liProficient in risk assessments, deviation and change management, root cause investigation analysis /li liExcellent writing skills and documentation practices /li liExcellent communication skills and command of English both written and oral /li liExcellent leadership and interpersonal skills; proven ability as team player and ability to manage cross‑functional teams. /li liExcellent planning and organizing skills /li /ul pLonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. /p /p #J-18808-Ljbffr