Innovative Medicine Project Delivery Synthetics Technical Lead

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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We are searching for the best talent for Innovative Medicine Project Delivery Synthetics Technical Lead to join our Engineering & Property Services team located in Beerse Belgium or Latina Italy.

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):

United States and Puerto Rico - Requisition Number: R-041526

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.

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.
  

Interfaces:

The key interfaces the SME works across are:

• J&J Engineering & Property Services (E&PS).
• E&PS Project leadership - Project Director E&PS Director (design construction and commissioning).
• J&J Quality Assurance.
• J&J Global Engineering and Technology (GET).

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
  

Qualifications:

• A minimum of a Bachelors engineering degree is required Masters/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.

#LI-Hybrid

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