Sr Manager, External Manufacturing Support Team (emst)

Sr Manager, External Manufacturing Support Team (EMST)

Johnson & Johnson Engineering & Property Services, Project Delivery Group is recruiting for a Sr Manager, External Manufacturing Support Team (EMST), to be located in New Brunswick, NJ or other key J&J sites in Pennsylvania, New Jersey and/or Puerto Rico.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

You will be responsible for assuring that our Contract Manufacturing Facilities (CMO's) are fit for their purpose and in alignment with Johnson & Johnson cGMP Facilities & clean utilities standards. You will assure the J&J Standard Design Platforms (SDPs) are met. This role is responsible for assessing potential gaps and providing solutions to highly complex technical problems within the external manufacturing space for our Pharma sector and will expand cross-sector in the future as it relates to Facilities cGMP readiness. You will be part of a multifunctional team that assesses new CMO sites and their lifecycle to assure their design and operability are cGMP compliant.

Key Responsibilities:

• Work with E&PS Project Delivery team to assess, deploy and implement the E&D's standard design platform by following the Fit for Purpose Process (F2P)
• Collaborate with various external manufacturing, equipment suppliers and system suppliers on how to ensure our external operations facilities are reliable & compliant at all times
• Continuously evaluate the latest advancement in technologies as it relates to purified water, WFI, HVAC, clean gases and people and material flows.
• Extensive knowledge of current regulations and requirements such as ANNEX 1
• Partner with various J&J groups to perform initial site assessment, remediation (if needed) and facility/utilities lifecycle support
• Understand the business needs of each of our sector stakeholders
• Support Requests for Proposal (RFP) for new CMO sites
• Assure that the J&J IDEA Project Delivery Process is followed, if applicable
• Establish plans for personal talent development, diversification, and professional development
• Collaborate closely with EHS, QA, Procurement, PES, TO, etc. on their deployments
• Develop personal yearly regional goals and objectives that support the overall J&J E&PS goals
• Execute short- and long-term tactical engineering plans and programs based on strategic departmental plans
• Lead Community of Practice in area of expertise.
• Lead a team of SME's cross sector to resolve highly technical challenges specific to clean utilities
• Build networks and maintain extensive contacts
• Understand and use the J&J Flawless Project Execution (FPX) process for project delivery
• Assure the appropriate J&J standards, guidelines, and regulatory requirements are incorporated
• Coordinate/lead key design reviews with SMEs including other corporate or affiliate resources such as EHSS, Risk Management, WW Security, etc.
• When applicable, review A/E progress and identify action plans where required. Implement Earned Value tracking on larger projects
• Lead effort to resolve key design conflicts in construction and commissioning phases
• Participate in the final close-out with the A/E firm including the Lessons Learned process
• Mentor other engineers

Qualifications

Education:

• BS in Engineering (Mechanical, Chemical, Electrical) or closely related technical degree is required. MS/MBA is preferred.

Experience:

Required:

• 10 years' experience in cGMP clean utilities design and facilities startup experience
• Experience designing/ constructing clean utilities & Master EU Annex-1 guideline
• Proficiency in project/design management, including obtaining agreement on project definition and priorities, and ensuring that resources, capabilities, and processes are in place to deliver the design, operations, or facilities set up efficiently and effectively
• Experience working in a Pharmaceutical regulated environment
• Ability to develop appropriate metrics for cGMP facilities design & construction performance and set up plans to provide continuous improvement
• Demonstrated history of collaboration across other functional areas to establish effective working relationships.
• Expertise delivering complex projects/programs on schedule and budget working with project teams

Preferred:

• Flawless Project Execution (FPX) training
• Bilingual in English & Spanish is an asset
• Professional Engineering License is an asset
• Prior experience working in a lead role at an A/E Design Firm or directly leading A/E Firms
• Experience working with Consumer and Med Device sectors of J&J and/or a clear understanding of different business models

Other:

• Up to 75% travel, both domestic and international, is required

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact the Employee Health Support Center.

The anticipated base pay range for this position is: $120,000-$207,000

Additional Description for Pay Transparency: 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 and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year, Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year, Holiday pay, including Floating Holidays – up to 13 days per calendar year, Work, Personal and Family Time – up to 40 hours per calendar year. Additional information can be found through the link below. For additional general information on Company benefits, please go to: