Sr Manager Commissioning & Qualification

Job Description - Sr Manager Commissioning & Qualification (******** W)

Sr Manager Commissioning & Qualification - ******** W

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 .

Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.

When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.

We are searching for the best talent for SR MANAGER COMMISSIONING AND QUALIFICATIONS to be in Costa Rica, Other Locations: [Latin America, North America]

Purpose:

At Engineering & Property Services (E&PS) we take care of all J&J buildings around the world providing end to end services from Real Estate, Engineering & Strategic Project Delivery to Facilities Management. We have a profound influence on the entire J&J Enterprise, providing innovative workplaces where our employees can collaborate and grow, and delivering flexible site solutions which enable our business to best serve our important customers and patients.

The Sr Manager, Commissioning & Qualification is accountable for overseeing of C&Q capital project implementation strategy from Concept 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 deliverables 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.

You will be responsible for :

· Act as primary C&Q interface with Project Delivery

o Drive the adoption of Risk Based Qualification in capital projects

o Drive the adoption of E2E C&Q Digital validation in capital projects

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

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

o Review affiliate qualification practices/procedures with respect to the project set up and intended C&Q approach

o Support local affiliate in any adjustments which may be required with the aim of crafting a robust, efficient C&Q strategy to suit the project

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

o Develop / support project handover strategy to the end users.Strategy to include training, operational readiness, document handover, operation strategy, as well maintenance and housekeeping strategy)

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

o Support the setup of a project C&Q strategy and detailed plan

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

o Support and advice on set up of project change management program

o Support Engineering Document Control process and VTOP/TTOP handover

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

o Set up and chair strategic and tactical C&Q workshops during capital projects to ensure alignment and identify gaps, then close gaps with project team as appropriate

o Lead project stage gate reviews for C&Q to ensure strategy is being implemented accurately and support issues as necessary

o Responsible for managing commissioning and qualification phase advancement

o Review all capital project specific engineering C&Q documentation

o Monitor and evaluate contractor safety performance throughout the duration of the project

o Provide oversight to project contractors to ensure Site C&Q Program methods are being utilized per procedures

Qualifications

Education:

• Technical Bachelor’s degree or equivalent required

Experience, Skills & Knowledge:

• Minimum of 8-10 years of relevant business experience with at least 5 years of leading commissioning and qualification
• Experience with current commissioning and qualification methods, including ISPE, ICH, and Risk-Managed approach
• Experience developing cost estimates and budgets
• Experience in leading groups of internal and external team members
• Knowledge of local regulatory requirements relevant to pharmaceutical and/or medical devices facilities
• Excellent problem solving and troubleshooting abilities
• High level of familiarity with, Excel, Word, and Microsoft Project
• Knowledge of Digital Validation platform (Kneat)
• Prior experience managing major capital (>10MM) projects

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive considerationfor 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.andEqual Employment Opportunity Posters GINA Supplement.

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