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 https://www.jnj.com/.

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. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong.

Experienced Validation Engineer – Equipment Process Validation

Cilag AG, part of Johnson & Johnson Innovative Medicine, is hiring an Experienced Engineer Equipment Process Validation in MSAT Biotherapeutics to enhance our team in Schaffhausen, Switzerland in an 80–100% role on a 24‑month fixed‑term contract.

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).

We belong to the Manufacturing Science & Technology (MSAT) organization for the MTO (Manufacturing and Technical Operations) Biotherapeutics and Synthetics Manufacturing Platform. We support the parenteral filling, visual inspection, device assembly and pack operations at J&J Innovative Medicine Schaffhausen.

Position Summary:

The Equipment Process Validation (EPV) team within MSAT is responsible for the validation and reliability of sterilization, decontamination, and primary container cleaning processes.

As an Experienced Validation Engineer in MSAT you will be responsible, alongside other team members, developing, maintaining, and optimizing reliable sterilization, decontamination, and primary container cleaning processes to meet current and future requirements. This involves collaborating in cross-functional teams within the site and exchanging knowledge with other locations worldwide.

Responsibilities:

• Develop and validate sterilization and decontamination processes.
• Creating protocols and reports for validations and monitoring, and supporting on-site activities.
• Develop and implement new strategies for Equipment process validation (EPV).
• Propose and support technical improvements to equipment and processes.
• Create documents for equipment process validation activities (protocols, reports, risk assessments, SOPs).

• Providing technical assessments of changes, CAPAs, and investigations.
• Assist experts in audits/health authority inspections.
• Maintaining excellent partnerships with all business partners at the site and within J&J.
• Coordinate EPV validation activities with other departments.
• Contribute to the digital transformation of MSAT (e.g., digitization and automation of reports, data management, visualization, evaluation of new technologies).
  

Qualifications:

• You have successfully completed your university studies in Engineering, Life Sciences or equivalent and have already gained experience (2+ years) in the pharmaceutical sector with past proven field experience in process validation (as part of operations, engineering, quality department etc.).

• You have proven experience in project execution, preferably in the live science and GMP environment. In addition to that you prefer an independent, self-initiative and goal-oriented way of working to apply your expertise and foster collaboration to reach fast paced goals according to management expectations and project schedules.

• Your strength is decision making and problem-solving, combined with excellent communication skills to represent MSAT in multi-functional and cross-sites teams within the global matrix organization.

• You are open to new ideas, and you drive innovation.

• You are interested in digital transformation and capable of proposing and implementing corresponding process improvements.

• You are proficient in English and German, both in communication and negotiation.

Why join Johnson & Johnson

A multifaceted challenge in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure at the J&J Innovative Medicine site Schaffhausen.

• Many opportunities to work on exciting projects and assignments in a dynamic work environment

• A broad spectrum of training opportunities to grow further for personal as well as professional development

• The Johnson & Johnson Pension Fund Switzerland offers attractive performance

• A range of benefits for insurance, childcare, products, sport, culture and much more
  
  

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Required Skills:

Preferred Skills: