MSAT Senior Validation Engineer

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

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

Cilag AG, part of Johnson & Johnson Innovative Medicine, is hiring a Senior Validation Engineer in MSAT Biotherapeutics to enhance our team in Schaffhausen, Switzerland (100%, 12 months 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:

You will be the Site MSAT representative on multi-functional teams leading process validations of automated visual inspection of pre-filled syringes, vials and cartridges as well as device assembly and packaging processes of pharmaceutical products at the Schaffhausen Fill Finish site. This involves collaborating in cross-functional teams within the site and exchanging knowledge with other locations worldwide.

You will provide the following:

• Technical support and leadership to top line growth
• Ensure reliability, compliance & efficiency of product value chains end to end
• Integrate manufacturing operations and pharmaceutical development in partnership with product and customer management

 

Responsibilities:

• Site MSAT lead SME for Device Assembly, Packaging and (Automated) Visual Inspection
• Accountable to meet project timelines during qualification and validation of visual inspection, device assembly and packaging lines and related processes.
• Own validation activities with internal partners and lead multi-functional project teams.
• Deliver on strategic project goals, process improvements and innovation to ensure competitiveness at the pharmaceutical market and with global players.
• Provide Technical Assessments to Change Controls/CAPAs and Deviations.
• Active participation in audits/health authority inspections as lead Subject Matter Expert.
• Maintain excellent partnership with all business partners.
• Perform statistical analyses on production data.

 

Qualifications:

• You have successfully completed your university studies in Engineering, Chemistry, Pharmacy or equivalent and have already gained experience (5+ years) in the pharmaceutical sector with past proven field experience in process validation (ideally in visual inspection, device assembly and packaging).
• 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.
• Proficient in both English and German is required.

 

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

Working at Johnson & Johnson is more than a job. We are changing the trajectory of Human Health and working with Johnson & Johnson can change everything. Including you. Learn more by watching this video.

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