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 pCompliance Engineer, Process Engineering (m/f) /p h3Main Task /h3 pThe Principal Engineer, Process Engineering is responsible for Engineering and Qualification; support Validation on process equipment, utilities facilities and computerized systems in CMT F2P2. /p ul liSupport the operation of the process equipment and production operation at the technical level in the Fill Finish pilot plant /li liTroubleshooting, rectification and documentation (troubleshooting, non-conformance management) in collaboration with production personnel, equipment suppliers and quality assurance /li liManagement of technical change and optimization processes (change control) systems and processes /li liSupervision of the technical order system in cooperation with mechanics and Technical Services /li liInstruction and training of employees on system and process level. Support in the evaluation and qualification of new technology-platforms/processes in the aseptic environment /li liCross-cutting project collaboration with other engineering functions at the local campus level and in the global engineering environment /li /ul h3Your profile /h3 ul liSpecifications design of process equipment and systems in the aseptic environment. /li liTroubleshoot equipment failures and define optimization and / or changes to existing equipment. Root-cause analyzation , definition of corrective actions and follow-up of implementations. /li liBuilding experience in process facility engineering, support GMP-compliance of facility, utilities and process equipment (e.g. COC, events, deviations, NC, qualification, support validation, ...) /li liWrite procedures, protocols, analyse data and write summary conclusions in reports. /li liBuilding experience and knowledge of HVAC, certification, monitoring
- Additional experience in the aseptic field is welcome /li liIdentify projects, create project plans and participate in their implementation. Perform evaluations to drive efficiency and business results. /li liOverall understanding of project budgeting processes and systems. /li liUnderstanding of the own role and the role of the department within the broader organization (CSC/DPDS/IMSC). /li liReadiness to lead a project team. /li liProvides an opportunity to explore process proof-of-principles to build up of knowlage for commercial process. Plans, coordinates and oversees validation operations, including scale up and optimization processes, equipment assembly, in process sample analysis, use of reactors, and preparation of compliance documents. /li liEvaluate analytical results to maintain and improve the quality of batches. /li liPropose and determine new or improved technologies to enhance product quality, manufacturing cost efficiencies, personnel safety and regulatory compliance. /li liStrong knowledge of aseptic fill finish and Annex 1/FDA compliance with all related regulatory guidelines to translate in a technical solution /li liBilingual German English /li li4-6 years’ of experience in the pharmaceutical/foot/chemical environment /li /ul h3Required

Skills:
/h3 pPreferred

Skills:
Agile Decision Making, Coaching, Critical Thinking, Emerging Technologies, Engineering, Problem Solving, Process Control, Process Engineering, Process Improvements, Product Costing, Product Improvements, Research and Development, SAP Product Lifecycle Management, Situational Awareness, Technical Research, Technical Writing, Technologically Savvy, Vendor Selection /p