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Distinguished process engineer - aseptic dp

Schaffhausen
8525-Cilag GmbH International Legal Entity
Prozessingenieur
Inserat online seit: 10 Juni
Beschreibung

PpJohnson Johnson is seeking a Distinguished Process Engineer - Aseptic DP. This position is an industry-leading technical authority in aseptic drug product biotherapeutic manufacturing (compounding, filtration, filling, and automated visual inspection). The role provides technical mentorship to project teams and work groups, offering overarching leadership in implementing new technologies, recommending improvements to enhance engineering and manufacturing efficiency, and evaluating and adapting new technologies. It also drives the development of technical standards ensuring seamless integration of new technology and engineering standards across multiple sites and cultivates future talent by mentoring internal engineers and encouraging a culture of aseptic engineering excellence. /ph3Responsibilities /h3ulliLeads the execution of engineering projects and initiatives ($1-$20M range) across multiple sites. /liliLeads project team members during project execution. /liliOversees multiple outside vendors and contractors. /liliAccountable for sophisticated engineering design and construction solutions delivery for manufacturing facilities, systems, equipment (compounding, filtration, filling, automated visual inspection). /liliProactively researches and implements new technologies to drive business growth and efficiency. /liliStays on top of industry trends through continued education participation in seminars / trade shows. /liliSpearheads the identification and development of new engineering standards for advanced technologies across the network. /liliCollaborates with Manufacturing Technology, Environmental and Health Safety, Engineering and Property Services, Quality Assurance, Sterility Assurance, Network Strategy, and Operations to ensure alignment with technology evaluation and technical standards. /liliOffers technical support for Global Business Development by leading technical assessments for LA (license/acquisition)/MA (merger/acquisition) business development opportunities. /liliAssesses network capabilities and strategic planning capacity across the platform. /liliProvides technical expertise and mentorship, ensuring compliance with policies, procedures, government regulations, and customer specifications. /liliProvides technical support to both the internal and external (CMO) Biotherapeutic and Synthetic aseptic drug product network to solve sophisticated technical engineering and manufacturing problems. /liliCultivates a culture of technical excellence, partnership, and innovation to enable multi-functional learning and standard methodology sharing. /liliDevelops and mentors engineering team members to ensure a strong talent pipeline. /liliRegularly updates senior management on project status, costs, and performance against targets. /li /ulh3Required Education /h3ulliBachelor of Science in Engineering; Chemical or Mechanical preferred. /liliMaster of Science in Engineering preferred. /li /ulh3Required Experience /h3ulli15 years of experience in a drug product Biotherapeutics engineering role. /li /ulh3Required Knowledge, Skills, and Abilities /h3ulliFluent in written and spoken German and English. /liliUnderstanding of cGMP’s for aseptic manufacturing of multiple regulatory bodies (EU, FDA), including fluency in the understanding of new EU Annex 1 guidelines and its impact on facility/equipment design. /liliHands‑on experience in the CQ (commissioning and qualification) of Biotherapeutic aseptic drug product process equipment (compounding, filtration, filling, and automated visual inspection). /liliAbility to synthesize strategies, business needs, engineering elements, and technology inputs into data‑driven business solutions. /liliDrive innovation and forward thinking for cGMP compliance. /liliStrong problem‑solving, communication, and decision‑making skills to drive impact in a fast‑paced evolving business landscape including highly sophisticated technical problems. /liliAbility to balance multiple priorities, maintain confidentiality, and communicate and operate with poise and integrity in a sophisticated, high‑profile, and evolving environment. /liliTrack record of developing and maintaining strong partnerships at all levels within the organization, including key stakeholders. /liliAbility to travel 30% (both internationally and within Europe). /li /ulh3Preferred Skills /h3ulliAgile Decision Making /liliCompliance Management /liliConsulting /liliCrisis Management /liliDesign Mindset /liliDisruptive Innovations /liliEmerging Technologies /liliLean Supply Chain Management /liliManaging Blended Teams /liliOperational Excellence /liliProcess Control /liliProcess Engineering /liliProduct Costing /liliProgram Management /liliProject Schedule /liliScience, Technology, Engineering, and Math (STEM) Application /liliTechnical Credibility /liliTechnical Research /li /ulpJohnson Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. /p /p #J-18808-Ljbffr

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