(Senior) Manager, MSAT LM DP Aseptic Process Simulation and Cleaning Validation

Job Description - (Senior) Manager, MSAT LM DP Aseptic Process Simulation and Cleaning Validation (2406227064W)

Description

Johnson & Johnson is recruiting for a (Senior) Manager, LM DP Aseptic Process Simulation & Cleaning Validation within the Manufacturing Science and Technology (MSAT) team located in Schaffhausen, Switzerland.

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.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

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.

Come and join us to create a future where disease is a thing of the past. Johnson & Johnson Innovative Medicine Schaffhausen Site/Cilag AG is a Launch site for new products with focus on Parenteral Products (e.g., pre-filled syringes and vials).

The Manufacturing Science & Technology (MSAT) team supports the Parenteral Small and Large Molecule Drug Product (DP) fill-and-finish operations at J&J Innovative Medicine in Schaffhausen.

Position Summary:

As an MSAT (Senior) Manager for Aseptic Process Simulation (APS) and Cleaning Validation (CV), you will be responsible for overseeing all aseptic process simulations, smoke studies, and cleaning validation activities related to our parenteral product portfolio and aseptic manufacturing equipment. Your role will focus on developing, maintaining, and improving these processes to support the organization’s goals of fostering innovation, enhancing productivity, reducing the cost of goods, and creating a competitive advantage.

Responsibilities:

• Organize and Lead the APS & CV Team: Manage and oversee a team of 6-10 engineers, ensuring their training, development, and overall performance.
• Define Strategy and Vision: Establish the strategy and vision for Aseptic Process Simulation (APS), Smoke Study and Cleaning Validation (CV) for the Cilag campus, ensuring alignment with evolving corporate standards, global regulatory expectations, internal benchmarks, and industry best practices.
• Provide Technical Support: Serve as the first line of technical support for aseptic manufacturing, cleaning, aseptic process simulation, and smoke study investigations.
• Collaborate with Business Partners: Work closely with business partners across the site, platform, and sectors to ensure compliance with submitted CMC dossiers and cGMP regulations.
• Act as Subject Matter Expert: Serve as a subject matter expert for aseptic manufacturing, cleaning, aseptic process simulation, and smoke studies during internal and external audits.
• Lead Process Improvements: Drive process improvement initiatives, impact assessments, and compliance gap analyses for marketed parenteral products.

Qualifications:

• Engineering or Life Science Degree
• At least 10 years experience in commercial pharmaceutical operations.
• At least 5 years of leadership experience.
• Proven ability to work effectively in local and global cross-functional teams within a matrixed environment.
• Familiarity with cGMP and regulatory requirements for validation processes.
• Strong organizational skills and the ability to follow through on tasks efficiently.
• Extensive experience in aseptic processing and cleaning for large and small molecule parenteral products.
• Fluent in German and English, with strong documentation and presentation skills.

We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure. If you are interested in this position, then please apply online including application letter, CV and ideally testimonials.

Primary Location

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability, please check our page for information on how to request an accommodation.