Senior Engineer, MSAT Biotherapeutic Drug Product

Johnson & Johnson seeks a Senior Engineer for MSAT Biotherapeutic Drug Product in Schaffhausen. This role leads process reliability for commercial and new biologic products within a hybrid work model.

The company is looking for a Site MSAT representative to join multi-functional teams at the Schaffhausen Fill Finish site. The position focuses on ensuring the reliability of product processes for commercial items and new product introductions (NPIs) involving biologic parenteral liquids, suspensions, and lyophilized products. The role bridges Manufacturing Operations and Pharmaceutical Development, collaborating closely with Product and Customer Management.

Responsibilities

• Act as the Site Technical Owner for NPI, technology transfer projects, and designated commercial products.
• Serve as the Subject Matter Expert for optical inspection processes, including defect trending and limit recalculation.
• Coordinate and own validation activities alongside internal partners.
• Lead or contribute to cross-functional project teams, providing technical guidance to meet quality, timeline, and compliance goals.
• Implement changes to improve process capability, quality, and cost efficiency.
• Provide end-to-end technical guidance for product lifecycle activities, such as Continued Process Verification (CPV) trending, change implementation, and continuous improvement.
• Offer technical feedback and assessments for deviations, investigations, CAPAs, and change controls related to drug product manufacturing.
• Participate actively in internal, customer, and health authority inspections as a lead Subject Matter Expert.
• Conduct statistical analyses on production data.

Requirements

• A Bachelor's degree or equivalent in Chemistry, Pharmacy, Engineering, or a related field is required.
• At least 4 years of relevant work experience.
• Experience in the Pharmaceutical, Biotechnology, or Life Science industry.
• Demonstrated ability to lead and execute projects, preferably within cross-functional teams.
• Strong decision-making and problem-solving skills, along with excellent communication and negotiation abilities.
• Proficiency in English, both oral and written.

Nice to have

• Proven experience supporting GMP manufacturing environments, including change control, lifecycle management, and hands-on leadership of GMP investigations.
• Strong background in drug product manufacturing, MSAT, process validation, tech transfer, and optical inspection topics.
• Solid knowledge of Quality Assurance, Regulatory Compliance, cGMP requirements, and EHS.
• Familiarity with statistical or data analysis tools (e.g., Minitab) and using production or quality data to support process understanding.
• Basic proficiency in German is strongly preferred.

What the company offers

• Flexible work policy allowing on-site work a minimum of three days each week, with the option for two remote workdays each week.

About the company

Johnson & Johnson is committed to its global workforce, providing an inclusive environment where every individual is valued. The company respects the diversity and dignity of its employees and recognizes their merit.

• Johnson & Johnson is responsible to its employees who work with them throughout the world.
• The company provides an inclusive work environment where each person is considered as an individual.
• Johnson & Johnson respects the diversity and dignity of its employees and recognizes their merit.