Director Commissioning and Qualification|
Johnson & Johnson is recruiting for a Director Commissioning and Qualification, located in the United States of America
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.
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 Director, Commissioning & Qualification is accountable for the development, deployment and quality implementation of the Detailed Process, Guidance and Templates to support the Commissioning & Qualification (C&Q) efforts within their assigned project(s).
This role is responsible for setting project-specific C&Q strategy and leading a C&Q team in the planning, execution and close-out of C&Q for major capital projects within the E&PS project portfolio.
An ideal candidate for this role will have proven experience in capital projects, process engineering and C&Q leadership from development through execution is required. Multi regional experience is preferred.
Key relationships include interface with Technical Leaders across Sectors and Functions (Project Management, Engineering, Quality, Operations, Procurement), as well as with External Project Partners (Construction Management Firms, Vendors, Qualification Service Providers).
- Oversight of all C&Q activities for all assigned project(s)
- Drive the adoption of Risk Based Qualification and implement continuous improvements and innovations.
- Provide guidance to the overall Project Execution Plan in order to ensure C&Q is accurately defined in alignment with E&PS practices for C&Q
- Create a project C&Q strategy and detailed plan for assigned project(s)
- Build C&Q schedule and start-up sequence (dependencies of systems)
- Review and refine qualification practices/procedures with respect to the project set up and intended C&Q approach. Implement any adjustments which may be required with the aim of crafting a robust, efficient C&Q strategy to suit the project
- Support and advise on set up of project change management program
- Build C&Q team and verify resource loading vs schedule
- Ensure automation / process control strategy is aligned with the overall C&Q strategy
- Develop and implement projects’ handover strategy to the end users. Strategy to include training, operational readiness, document handover, operation strategy, as well maintenance and housekeeping strategy
- Set up and chair strategic and tactical C&Q workshops to ensure alignment and identify gaps; close gaps along with project team as appropriate
- Lead stage gate reviews for C&Q to ensure strategy is being implemented accurately and support issues as necessary
- Participate in the Global C&Q COE to promote SMEs development and skills improvement
- Review qualification practices / procedures to support the alignment with the latest industry practices and guides
- Forge internal collaboration across levels of the enterprise
- Translate insights into innovative and viable solutions that build value
Lead partnership with external pre-qualified C&Q global providers while training these partners on J&J’s Risk-Based Qualification methodology to facilitate their engagement in the capital projects
- Bachelor’s degree in Engineering from an accredited institution required
- Masters / MBA preferred
Experience and Skills:
- Minimum 12 years of experience in the pharmaceutical industry including capital projects, process engineering, equipment design, commissioning & qualification
- Proven knowledge of C&Q methodologies and the current industry guides and practices
- Strong knowledge of GxP requirements
- Strong capability to collaborate with and influence technical leaders across different J&J sectors and functions, as well as external project partners (AE firms, CE firms. C&Q partners, etc.)
- Proven experience in establishing external relationships and benchmarking
- Strong negotiation skills
- Global and enterprise-wide mentality coupled with strong communication skills (verbal & written), and the ability to articulate ideas to influence different levels of leadership ensuring alignment of C&Q methodologies across projects and sectors
- PMP Certification preferred
- PE Licensed preferred
- Six Sigma Black Belt Certificate preferred
- Must be fluent in English
- 50% travel to and from the project site. Relocation available
- The anticipated base pay range for this position is $133,000 to $199,000
- The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
- Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.
- For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
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.]
United States-New Jersey-New Brunswick-One Johnson & Johnson Plaza
North America-United States-Illinois-Chicago, North America-United States-Massachusetts-Boston, North America-United States-Pennsylvania-Philadelphia, North America-United States-Georgia-Atlanta, North America-United States
Johnson & Johnson (6067)