Senior Engineer, MSAT Biotherapeutic Drug Product

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.

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.

• Minimum of a Bachelor's/University or equivalent degree is required; focused degree in Chemistry, Pharmacy, Engineering, or related field is preferred

• 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

• 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

• 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