Manufacturing Execution System (MES) Project Lead

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions 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 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 Beerse 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 Beerse 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 Beerse business

• Project expert and project manager for the Beerse 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 (FPOs)

• 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 SMEs 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 Bachelors degree in science-based discipline is required. A Bachelors 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 & Dutch (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 worlds 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

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