Senior Compliance Engineer, Process Engineering

pAt Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. /p pAs guided by Our Credo, Johnson Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit. /p h3Job Function: /h3 pRD Product Development /p h3Job Sub Function: /h3 pRD Process Engineering /p h3Job Category: /h3 pScientific/Technology /p h3All Job Posting Locations: /h3 pSchaffhausen, Switzerland /p h3Job Description: /h3 h3Senior Compliance Engineer, Process Engineering (m/f) /h3 pThe Senior Compliance Engineer, Process Engineering, is responsible for Engineering and Qualification; support Validation on process equipment, utilities facilities and computerized systems in CMT F2P2. /p h3Main Tasks /h3 ul liProvide technical support for operation of process equipment and production in the Fill Finish pilot plant. /li liLead troubleshooting, corrective action and documentation efforts for technical issues and non-conformances, collaborating with production teams, equipment suppliers and Quality Assurance. /li liManage technical changes and optimization initiatives through the change control process. /li liOversee the technical work order system in cooperation with mechanics and Technical Services. /li liDeliver training and instructions to operators and staff at system and process level. /li liSupport evaluation, qualification and implementation of new technology platforms/processes in an aseptic environment. /li liCollaborate across engineering functions locally and within the global engineering organization on cross-functional projects. /li /ul h3Your profile /h3 ul liProven experience specifying and designing process equipment and systems for aseptic environments. /li liStrong troubleshooting skills: perform root cause analysis, define corrective actions and ensure implementation and follow-up. /li liExperience in process and facility engineering with hands-on support for GMP compliance of facilities, utilities process equipment (e.g., change controls, deviations, NCs, qualifications, support for validation). /li liExperience writing procedures and protocols, analysing process data and producing clear technical reports with conclusions and recommendations. /li liKnowledge of HVAC systems, certification and monitoring; previous aseptic-fill/sterile manufacturing experience is an advantage. /li liAbility to identify improvement projects, create project plans and participate in delivery to drive efficiency and business outcomes. /li liGeneral understanding of project budgeting and basic financial processes. /li liAwareness of the department's role within the broader organization (CSC/DPDS/IMSC) and readiness to lead project teams. /li liExperience planning and coordinating validation and scale-up activities, equipment assembly, in-process sampling, reactor use and preparation of compliance documentation. /li liAbility to evaluate analytical results to maintain and improve batch quality. /li liPropose and implement new or improved technologies to enhance product quality, manufacturing cost-efficiency, personnel safety and regulatory compliance. /li liSolid knowledge of aseptic fill-finish operations and regulatory requirements (Annex 1 / FDA guidance) and the ability to translate these into technical solutions. /li li4-6 years' experience in the pharmaceutical, food or chemical industry. /li liFluent in German and English (written and spoken). /li /ul h3Preferred Skills: /h3 ul liAgile Decision Making /li liCoaching /li liCritical Thinking /li liEmerging Technologies /li liEngineering /li liProblem Solving /li liProcess Control /li liProcess Engineering /li liProcess Improvements /li liProduct Costing /li liProduct Improvements /li liResearch and Development /li liSAP Product Lifecycle Management /li liSituational Awareness /li liTechnical Research /li liTechnical Writing /li liTechnologically Savvy /li liVendor Selection /li /ul #J-18808-Ljbffr