Manufacturing Execution System (MES) Project Lead

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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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/.

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 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 Schaffhausen 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 (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 & 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 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

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.