Technical Support Group Lead, Innovative Medicine Project Delivery (USA)

Technical Support Group Lead

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.

The Technical Support Group Lead is responsible for leading a team of industry experts in Biotherapeutics, Synthetics, Advanced Therapies and Medicinal Products; to deliver a standard end to end technical support for capital projects from concept to handover, encompassing the following key areas:

• Facility business need
• Facility design
• Facility construction, commissioning and handover
• Facility process validation
• Asset management readiness
• Project management operations and governance

Responsibilities include:

• Define and deploy a vision and strategy for a standard technical approach, for all IM capital projects.
• Oversee the creation of all necessary Facility and Equipment processes and standards; to ensure the safe, compliant and reliable transition from project build phase to start-up phase – from design to construction to commissioning to handover to operations and maintenance.
• Provide end to end expert engineering technical support and guidance to capital projects from concept to handover; in the key areas of facility business need, facility design, construction, commissioning and process validation; for strategic green field and brown field Innovative Medicines facilities.
• Provide guidance and overarching technical leadership in Facility & Equipment design.
• Oversee the creation of all necessary asset management engineering standards and processes; to ensure the safe, compliant and reliable transition from project build phase to operations phase.
• Provide leadership and oversight to the site asset management functions, including creating a vision, a strategy, an operating model and an operating budget.
• Provide technical support to the setup of asset management organizational structures, business processes, procedures, technology and systems including CMMS, data management, 5-year asset management plan, smart condition based and predictive maintenance philosophy.
• Incorporate IM Managing Assets and FM Hard Services requirements into one cohesive site asset management approach.
• Work across the project team and the end state site engineering team, to ensure both teams integrate and work closely during the project phase, ensuring constant collaboration and a seamless handover from project to operations.
• Ensure that IDEA and all other related business processes are followed and fully adopted by maximizing the value and impact to the business; including governance, approvals, resourcing, prioritization, network alignment, cash flow, risk management and performance management.
• Work in close collaboration with JJIM business units, provide strategic insights into the growth strategy and future pipeline.
• Establish an End-to-End capital projects management performance framework, which encompasses an annual portfolio of over $8BB, to deliver optimal value for E&PS and IM.
• Define clear and strategic objectives for capital prioritization that align with the organization's overall requirement of the IM R&D, Supply Chain and Commercial organization and allocate capital efficiently across a diversified range of investments.
• Establish a process excellence framework for strategic large capital projects, to define and govern key deliverables for each project phase. Research, define and deploy an associated software system to digitize the governance process.
• Utilize data-driven insights and market intelligence to inform future decision-making. Stay informed on industry and regulatory trends and adapt strategies accordingly to achieve excellent portfolio performance.
• Lead the External Manufacturing assessment program, by deploying a consistent and standard approach for assessment, monitoring and controlling external manufacturing facility performance.
• Lead and develop a high-performing organization fostering a culture of collaboration, accountability, and innovation.
• Mentor and coach engineering technical leaders and experts and cultivate talent within the organization to ensure optimal management and delivery of capital programs.
• Collaborate with the Global Engineering Technology (GET) team to ensure alignment with technology standards, project execution and engineering specifications for manufacturing technology.
• Ensure compliance with policies, procedures, government regulations, and customer specifications.
• Proactively research and implement new standards to drive business growth and efficiency.
• Report out to senior management regularly on activities and status.

Interfaces include:

• Collaborate closely with all E&PS functions, IM business partners, Finance, Procurement, HR, IT, QA, and EHS teams.
• J&J Engineering & Property Services (E&PS)
• Strategic Project Delivery leadership - Project Director, E&PS Director (design, construction and commissioning)
• J&J Quality Assurance
• J&J Global Engineering and Technology (GET)
• J&J Site Engineering teams

Requirements include:

• Facility design
• Facility construction
• Facility commissioning and qualification
• Asset Management
• Maintenance, Calibration and Reliability management
• Biotherapeutics, Synthetics, Advanced Therapies and Medicinal products
• External Manufacturing Operations

Qualifications include:

• A minimum of a Bachelor's engineering degree is required, Master's/MBA/PhD is required.
• A minimum of 20 years' experience in the pharmaceutical manufacturing industry is required.
• Hands on experience designing, constructing, commissioning or qualifying manufacturing process equipment is required.
• A minimum of 20 years asset management, maintenance, reliability and project engineering is required.
• A minimum of 5 years' experience in a global technical leadership role.
• A minimum of 10 years large capital project management experience over $500 million is required.
• Able to balance multiple priorities, communicate and operate with poise and integrity in a sophisticated, high-profile, and evolving environment is required.
• Must be fluent in written and spoken English.
• This position requires a minimum of 25% domestic and international travel.
• The primary work location is a hybrid remote and in office environment.

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.

The anticipated base pay range for this position is: $173,000 --- $299,000 USD Annual