Job Description:

Cilag AG, part of Johnson & Johnson Innovative Medicine, is hiring a Principal Engineer New Product Launch in MSAT Biotherapeutics to enhance our team in Schaffhausen, Switzerland.

Johnson & Johnson Innovative Medicine Schaffhausen Site/Cilag AG is a Launch site for 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 aseptic filling, visual inspection, device assembly and packaging operations at J&J Innovative Medicine Schaffhausen.

Position Summary:

You will act as Site MSAT representative, leading the site Lauch Center of Excellence (COE). You will oversee all aspects of global product launch activities, coordinate cross-functional teams, and drive timelines to deliver impactful market entry.

Responsibilities:

• Align with the Supply Chain Development Lead and the Site launch team and assure flawless execution of the launches of new pharmaceutical products per the defined strategy, including timelines, milestones, and resource plans.

• Conduct risk assessments and develop contingency plans to mitigate launch risks.

• Engage with internal and external stakeholders across the cross-functional team to secure necessary approvals, licenses, and certifications.

• Collaborate with Regulatory Affairs, Planning, Manufacturing, Quality and Supply Chain teams to ensure seamless launch activities.

• Oversee and coordinate manufacturing, labeling, packaging and shipping activities providing proactive leadership on issue resolution to ensure launch milestones are met according to schedule.

• Monitor launch performance, gather stakeholder feedback, and implement post-launch optimization strategies.

• Ensure that all launch activities adhere to Good Manufacturing Practices (GMP) and industry standards.

• Prepare and present progress reports, launch performance metrics, and post-launch review findings to senior management.

• Provide Technical Assessments to Change Controls/CAPAs and Deviations related to packaging, labeling and product launch activities.

• Deliver on strategic project goals, process improvements and innovation to ensure competitiveness in the pharmaceutical market and with global players.

• Maintain excellent partnership with all business partners.

Qualifications:

• You have a Bachelor's or Master's degree in Life Sciences, Engineering, Pharmacy, or a related field, complemented by 7+ years of proven experience in labeling and packaging for the pharmaceutical, biotech or medical device industry, including significant hands-on field experience in product launch management.

• You have demonstrated experience with applicable FDA, EMA and ICH regulations related to product artwork, labeling and packaging. Experience in combination products and applicable regulations is a plus.

• You have strong project management, planning, and organizational skills with a demonstrable track record of successful project execution, preferably within live science and GMP environments.

• You thrive working independently, taking initiative, and proactively applying your expertise to meet fast paced goals and project milestones in alignment with management expectations.

• You have excellent decision-making and problem-solving abilities, paired with outstanding communication skills, enabling you to effectively represent MSAT in cross-functional, multi-site teams within a global matrix organization.

• You have exceptional stakeholder management skills with the agility to adapt swiftly to evolving regulatory landscapes and market dynamics.

• You are fluent in English and German, with the ability to communicate complex concepts clearly and persuasively across diverse stakeholder groups.

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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