Senior Engineer, MSAT Biotherapeutic Drug Product

Job description

At 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. As 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. Job Function: Supply Chain Engineering Job Sub Function: Process Engineering Job Category: Scientific/Technology All Job Posting Locations: Schaffhausen, Switzerland Job Description: Senior Engineer, MSAT Biotherapeutic Drug Product (PG26)About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine. We are searching for the best talent for Senior Engineer, MSAT Biotherapeutic Drug Product (DP)! This hybrid position will be located in Schaffhausen, Switzerland. As a member of the Site Technical Owner (STO) Team, the Senior MSAT Bio DP Engineer will serve as the Site MSAT representative on multi-functional teams and is responsible for leading the reliability of product processes of commercial product and new product introductions (NPI's) for biologic parenteral liquids, suspensions, and lyophilized products at the Schaffhausen Fill Finish site. This involves collaborating in multi-functional teams within the site and exchanging knowledge with other locations worldwide. They will provide technical support and leadership to top-line growth, as well as ensure reliability, compliance, and efficiency of product value chains end-to-end (E2E). The Site MSAT Rep will also integrate Manufacturing Operations and Pharmaceutical Development, in partnership with Product and Customer Management. Responsibilities:Serve as Site Technical Owner for NPI, Tech Transfer Projects, and specific commercial products Serve as Subject Matter Expert for Optical inspection related processes, e.g. Defect Trending, Limit Recalculation Own and coordinate validation activities with internal partners Lead or contribute to multi-functional project teams, providing technical guidance and coordinating activities to meet quality, timeline, and compliance objectives Implement process capability, quality, and cost improvement changes Support E2E technical guidance for product lifecycle activities, including Continued Process Verification (CPV) trending, change implementation, and continuous improvement Provide technical feedback and assessments for deviations, investigations, CAPAs, and change controls related to drug product manufacturing processes Active participation in internal, customer, and health authority inspections as lead Subject Matter Expert Maintain excellent and collaborative relationships with all business partners Perform statistical analyses on production data QUALIFICATIONS:EDUCATION:Minimum of a Bachelor's/University or equivalent degree is required; focused degree in Chemistry, Pharmacy, Engineering, or related field is preferred EXPERIENCE AND SKILLS:Required:Minimum 4 years of relevant work experience Experience in the Pharmaceutical, Biotechnology, and/or Life Science industry Demonstrated ability to lead and execute projects, preferably as part of cross-functional teams and/or projects Strong decision-making and problem-solving competencies, combined with excellent communication and negotiation skills Flexible, motivated, team-player, open to new ideas and driving innovation Preferred:Proven experience supporting GMP manufacturing environments, including change control, lifecycle management activities, and hands-on leadership of GMP investigations Strong background in drug product manufacturing, MSAT, process validation, tech transfer, and optical inspection related topics Solid knowledge of Quality Assurance, Regulatory Compliance, cGMP requirements, and EHS Familiarity with statistical or data analysis tools (e.g., Minitab or similar) and use of production or quality data to support process understanding OTHER:·Requires proficiency in English (oral and written); basic proficiency in German is strongly preferred·May require up to 10% domestic and/or international travel·Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week Required Skills: Preferred Skills: Agile Decision Making, Coaching, Corrective and Preventive Action (CAPA), Critical Thinking, Emerging Technologies, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Product Costing, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy, Validation Testing, Vendor Selection