Johnson & Johnson is currently seeking a Schaffhausen Manufacturing Execution System (MES) Project Lead to join our team located in Schaffhausen, Switzerland.
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The successful candidate will be responsible for leading the site project team to deliver the major site transformation project in implementing a Manufacturing Execution System for the manufacturing operations in Schaffhausen using new integrated technologies called Next Gen Manufacturing platform. This will be a phased project involving conversion of all manufacturing batch information/records from a document-based system to a full integrated digital system with workflow management. The system will be integrated to multiple key systems (e.g. Manufacturing equipment, SAP, LIMS, Truvault etc.).
ROLE:

• Lead & deliver MES Project for Schaffhausen site
• Primary contact between project team, sponsor and steering committee
• Ensure project team representation is aligned with project objectives and delivers integrated MES solution for Schaffhausen business
• Project expert and project manager for the Schaffhausen site
• Champion for project execution

RESPONSIBILITY:

• Own overall execution and program delivery within scope, schedule, budget and quality/regulatory requirements.
• Responsible for verifying planned changes and gaps with local stakeholders / users
• Responsible for project Risk Mitigation planning
• Maintain a strong relationship with DOTS, to drive E2E deployment excellence for systems, and JJT, to co-develop new technical capabilities into Next gen Manufacturing platform
• Confirm, monitor and deliver all Final Project Objectives (FPO’s)
• Overall accountability and responsibility for successful and on time and in budget execution of deployment, across all work streams and functions
• Manage the deployment to ensure timely/high quality deliverables
• Own project planning, resourcing, monitoring and adherence to plan
• Maintain and control project budget
• Work with Cross Deployment Leader to provide clear and consistent communications to Steering Committee and Project Sponsor & escalations
• Ensures conformance to the Global Template and deployment methodology
• Partner with the Business Lead to ensure that the end-state, integrated, solution meets business needs across all impacted functions (end-to-end)
• Strongly collaborate with the Next Gen MES Deployment Lead and Excellence Lead in DOTS to define and execute deployment standards
• In alignment with Deployment Excellence lead setup concepts to efficiently and effectively deliver the MES execution with highest RFT
• Manage template changes/ customization in response to business statutory & regulatory needs
• Ensure integration of functional experts and business SME’s, in order to establish a holistic project execution team
• Provide proactive communications about project activities to key stakeholders, managing internal (Site) and external (global organization) stakeholders
• In strong partnership with Business Lead, drive change management to align the organization with new business capabilities

Qualifications

• Minimum of a Bachelor’s degree in science-based discipline is required. A Bachelor’s or higher degree in Life Sciences discipline, Pharmacy or Chemical Engineering is preferred.
• Minimum 10 years of experience in operations and project management in Pharmaceuticals.
• Knowledge of the applicable regulations and regulatory processes.
• Demonstrated knowledge of Good Manufacturing Practice (GMP) regulations; proven understanding of GAMP and SDLC requirements is preferred
• Knowledge in Quality and/or Regulatory Compliance field, preferably in Pharmaceuticals is considered an asset.
• Ability to work across organizational boundaries in a global matrix organization, through influence, negotiation and partnering for changes requiring buy-in from all stakeholders at all levels.
• Strong decision making and problem solving competencies
• Strong conceptual leadership skills
• Knowledge of Automation and IT related systems in regulated environment
• Language capability - Must be proficient in English & German (oral and written).

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.
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