Innovative Medicine Project Delivery Synthetics Technical Lead

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

22h•Hybrid

About The Position

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Engineering Job Sub Function: Project Engineering Job Category: People Leader All Job Posting Locations: Athens, Georgia, United States of America, Gurabo, Puerto Rico, United States of America, Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: We are searching for the best talent for Innovative Medicine Project Delivery Synthetics Technical Lead to join our Engineering & Property Services team located in New Brunswick, NJ, Raritan, NJ, Titusville, NJ, Malvern, PA, Horsham, PA, Spring House, PA, Athens, GA, or Gurabo, PR. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Beerse, Belgium and Latina, IT - Requisition Number: R-042378 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. In 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 Innovative Medicine (IM) Project Delivery (PD) Synthetics Technical Lead is part of the Project Delivery Technical Support Group (TSG), that provides end to end technical support to all capital projects from concept to handover. As an industry-leading expert, the SME provides guidance and overarching technical leadership in Facility design. This role involves significant technical leadership responsibilities. The Synthetics Technical Lead is responsible for providing expert engineering technical support and guidance; in the key areas of facility business need, design, construction, commissioning and process validation; for strategic green field and brown field Small Molecule Synthetics API and Drug Product facilities. Key to this role is technical leadership in defining and deploying a vision and strategy for a standard Facility and Equipment design, for all IM Synthetics capital projects. The Synthetics Technical Lead is responsible for overseeing the design and 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. The Synthetics Technical Lead is responsible for keeping abreast of all current industry and regulatory standards, to ensure IM Synthetics manufacturing plants are designed, built and commissioned to leading edge industry standards. The Synthetics Technical Lead works 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.

Requirements

We are seeking a dynamic and motivated individual with strong technical background, excellent communication skills and a proven track record of driving engineering excellence to lead the development and implementation of leading-edge engineering standards across our platform.
The candidate will drive innovative facility process design, ensuring seamless integration at all sites.
The candidate must have expert knowledge in the following areas: Small Molecule Synthetics API: Raw Materials Handling Product Synthesis Centrifugation Product Recovery, Isolation & Purification Drying & Milling Packaging & Inspection Out of Place Cleaning Process In Place Cleaning Process Cleaning Validation Process Waste Handling Technologies & Systems Gowning Requirements Materials, People & Waste Flows Small Molecule Synthetics Drug Product: OSD Batch Manufacturing OSD Continuous Manufacturing Wet Granulation Dispensing & Sizing Powder Blending Dry Granulation Direct Compression & Encapsulation Lubrication Wet Screening Dry Screening Tableting, Coating or Capsule Filling Drying Extra Granular Addition Bottle Filling Blistering Packaging & Inspection Out of Place Cleaning Process In Place Cleaning Process Cleaning Validation Process Waste Handling Technologies & Systems Gowning Requirements Materials, People & Waste Flows
A minimum of a Bachelor's engineering degree is required, Master's/MBA/PhD is preferred.
A minimum of 12 years of manufacturing, project engineering, supply chain and capital project execution in the Small Molecule Synthetics API and Drug Product Industry is required.
Hands on experience designing, constructing, commissioning or qualifying manufacturing process equipment is required.
Strong Small Molecule Synthetics API and Drug Product process engineering expertise is required.
Large capital project management experience over $200 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.

Responsibilities

Keep abreast of all current industry and regulatory standards and trends (483s, audit reports, etc.), to ensure IM Synthetics manufacturing plants are designed, built and commissioned to leading edge industry standards, through continued education and participation in seminars and trade shows.
Define and deploy a vision and strategy for a standard Facility and Equipment design, for all IM Synthetics capital projects.
Oversee the design and 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.
Develop new engineering standards for facility design for Small Molecule Synthetics.
Provide expert engineering technical support and guidance; in the key areas of facility business need, design, construction, commissioning and process validation; for green field and brown field Small Molecule Synthetics API and Drug Product facilities.
Nurture future talent, by mentoring both internal and external engineers.
Collaborate with the Global Engineering Technology (GET) team head 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.

Benefits

medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
consolidated retirement plan (pension) and savings plan (401(k)).
long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours