Johnson & Johnson is seeking a highly skilled Director, Commissioning & Qualification in the Commissioning & Qualification field. This position will be located in North Carolina.
In this role as Director, Commissioning & Qualification, you will have the exceptional opportunity to lead the C&Q activities and Engineering Document Control in large capital projects, from Strategy to Business Readiness, including aspects of project planning, 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 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 Responsibilities:
- Lead the C&Q and EDC team:
- Lead the team of internal and external resources that will deliver C&Q effort in the project.
- Collaborate with Project Delivery:
- Drive the adoption of Risk Based Qualification in capital projects
- Drive the adoption of E2E C&Q Digital validation in capital projects
- Ensure alignment with J&J standards along with engineering methodologies and practices.
- Provide guidance to the overall Project Execution Plan to ensure C&Q is accurately defined in alignment with E&PS practices:
- Review affiliate qualification practices/procedures with respect to the project set up and intended C&Q approach
- 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
- Ensure automation / process control strategy is aligned with the overall C&Q strategy
- Develop / support project handover strategy to the end users.
- Supports project, in effectively scheduling, coordinating, mentoring and reviewing project activities with appropriate functional groups:
- Support the setup of a project C&Q strategy and detailed plan
- Lead the development of proposed C&Q schedule and start-up sequence (dependencies of systems), and resource loading
- Support and advise on set up of project change management program
- Support Engineering Document Control process, including VTOP/TTOP handover and Drawings handover
- Drive effective and efficient execution of C&Q program to deliver quality project outcomes meeting performance expectations:
- 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
- Lead project stage gate reviews for C&Q to ensure strategy is being implemented accurately and support issues as necessary
- Report out on C&Q progress to senior management
- Responsible for leading commissioning and qualification phase advancement
- Responsible for appointing C&Q contract
- Accountable for safe, on time, on budget completion of all C&Q Firm field execution activities
- Lead all aspects of review and approval of all capital project specific engineering C&Q documentation
- Monitor and evaluate contractor safety performance throughout the duration of the project
- Provide guidance to project contractors to ensure Site C&Q Program methods are being used per procedures
- Lead Engineering Document Control process and VTOP/TTOP handover:
- Ensure VTOP/TTOP process is aligned to J&J standard
- Ensure VTOP/TTOP process is managed fully digital, till handover phase
- Ensure VTOP/TTOP is verified and aligned to J&J expectations
- Ensure all project drawings are as-built accurately and all drawings are uploaded to Enterprise drawing management system
Qualifications
Education:
- University/Bachelor’s or equivalent degree in Engineering or other related scientific field from an accredited institution required; Masters/MBA preferred
Experience and Skills:
Required:
- Minimum of ten to twelve (10-12) years of relevant experience
- Experience in the pharmaceutical industry including capital projects, process engineering, equipment design, commissioning & qualification
- Multi-regional / Global experience
- Proven knowledge of C&Q methodologies and the current industry guides and practices
- Strong knowledge of GxP requirements
- Experience developing cost estimates and budgets
- 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.)
- Experience in leading groups of internal and external team members
- Knowledge of local regulatory requirements relevant to pharmaceutical and/or medical devices facilities
- Working knowledge of engineering documentation control processes and systems
- Excellent problem solving and fixing abilities
- Proven experience in establishing external contacts 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
Preferred:
- Diverse knowledge in the pharmaceutical industry, with exposure to product development, tech transfer, and quality is an additional asset but not required
- Advanced training skills
Other:
- Must be proficient (written and spoken) in the English language
- This position will require up to 50% domestic and international travel
- PMP Certification preferred
- Six Sigma Black Belt Certificate preferred
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.
