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Job Information

J&J Family of Companies Sr Manager, Commissioning & Qualification in Morrisville, North Carolina

Sr Manager, Commissioning & Qualification - 2406215995W

Description

Johnson & Johnson is seeking a highly skilled Sr. Manager, Commissioning & Qualification in the Commissioning & Qualification field. This position is will be located in North Carolina.

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/.

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.

Apply now to join our ambitious team and make a meaningful impact on the world through our outstanding engineering opportunities at Johnson & Johnson.

In this role as Sr Manager, Commissioning & Qualification, you will have the exceptional opportunity to lead the C&Q activities in large capital projects, from Strategy to Business Readiness, including aspects of project planning, training, resource management, execution logistics, close-out, document management, VTOP/TOTP handover and application of lessons learned.

This role is responsible for ensuring compliance with all applicable regulatory, J&J Quality standards and industry best practices in Capital Projects.

A suitable candidate for this role will have strong working relationships with partners (project delivery, quality, operation, system owner and tech. transfer) to ensure high quality results meeting cGMP and site quality requirements. Will also be a self-starter with strong interpersonal, organizational, and technical skills.

Key relationships include working closely with the regional Local teams of the different business segments, E&PS Project Delivery Teams, Project Controls, Engineering & Design, and the CoE within the strategic project delivery group.

Key Responsibilities:

  • Act as primary C&Q interface with Project Delivery team

  • Drive the adoption of Risk Based Qualification in capital projects

  • Drive the adoption of E2E C&Q Digital validation in capital projects using Kneat

  • Ensure alignment with J&J standards along with engineering methodologies and best practices.

  • Provide recommendations to the overall Project Execution Plan to ensure C&Q is accurately defined in alignment with E&PS practices

  • Setup of a project C&Q strategy and detailed plan

  • Ensure automation/process control strategy is aligned with the overall C&Q strategy

  • Support project handover strategy to the end users.

  • Supports project, in effectively scheduling, coordinating, mentoring and reviewing project activities with appropriate functional groups

  • Lead the development of proposed C&Q schedule and start-up sequence (dependencies of systems), and resource loading

  • Drive effective and efficient execution of C&Q program to deliver quality project outcomes meeting performance expectations.

  • Supervise and evaluate C&Q contractor safety performance throughout the duration of the project

  • Lead project stage gate reviews for C&Q to ensure strategy is being implemented accurately and improvements are identified

  • Support and advice on set up of project organizational change program

  • Support Engineering Document Control process and VTOP/TTOP handover

Qualifications

Education:

  • A minimum of a Technical Bachelor's or equivalent degree in Engineering is required; Master's degree preferred

Experience

Required:

  • Minimum of eight (8) years of relevant business experience

  • Experience in Commissioning and Qualification, Engineering or Quality

  • Knowledge of regulatory requirements relevant to Commissioning and Qualification

  • Experience in leading groups of internal and external team members

  • Excellent problem solving and troubleshooting abilities

Preferred:

  • Global experience is beneficial

Other:

  • May require up to 10% domestic and/or international travel

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

Primary Location NA-US-North Carolina-Morrisville

Other Locations NA-US-North Carolina

Organization Johnson & Johnson Surgical Vision, Inc (6234)

Relocation Eligible: No

Travel Yes, 25 % of the Time

Job Function Project Engineering

Req ID: 2406215995W

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