IM PD Bio-Therapeutics Technical 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. Learn more at https://www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub Function:

Project Engineering

Job Category:

People Leader

All Job Posting Locations:

Cork, Cork, Ireland, Leiden, Netherlands, Schaffhausen, Switzerland

Job Description:

We are searching for the best talent for Innovative Medicine Project Delivery ATMP Technical Lead to join our Engineering & Property Services team. This position can be located in New Brunswick, NJ, Raritan, NJ, Titusville, NJ, Malvern, PA, Horsham, PA, Cork Ireland, Schaffhausen Switzerland or Leiden, Netherlands.

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):

US- Requisition Number: R-041523

EMEA- Requisition Number:

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 Medicines (IM) Project Delivery (SPD) Subject Matter Expert (SME) 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 Bio-Therapeutics 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 Drug Substance 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 capital projects.

The Bio-Therapeutics 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 Bio-Therapeutics Technical Lead is responsible for keeping abreast of all current industry and regulator standards, in order to ensure IM manufacturing plants are designed, built and commissioned to leading edge industry and regulatory standards.

The Bio-Therapeutics Technical Lead works across the project team and the end state site engineering team, to ensure both teams integrate together 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.), in order to ensure IM Bio-Therapeutics manufacturing plants (Drug Substance and Drug Product) are designed, built and commissioned to leading edge industry standards, through continued education and participation in seminars, technical and regulatory conferences and trade shows.
• Define and deploy a vision and strategy for a standard Facility and Equipment design, for all IM Bio- Therapeutics 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 Bio-Therapeutics.
• 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 Drug Substance 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 Bio-Therapeutics Technical Lead 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:

Drug Substance:

• Cell Vials Cryo-Preservation & Thawing
• Media Preparation, Storage & Transfer
• Cells Pre-Culture & Cell Culture
• Cell Separation & Harvest
• Buffer Preparation
• Chromatography Columns Process
• Viral Inactivation and Filtration Process
• Ultra-Filtration/ Dual-Filtration Process
• Final Bulk Filling Process
• Cold Chain Management
• Out of Place Cleaning Process
• In Place Cleaning Process
• Out of Place Sterilization Process
• In Place Sterilization Process
• Cleaning Validation
• Sterilization Validation Process
• Waste Handling Systems
• Gowning Requirements
• Materials, People & Waste Flow

Drug Product, Device Assembly & Packaging:

• PFB Storage & Pooling
• PFP Thawing
• PFB Formulation and Filtration
• Containers Washing and Depyrogenation (Vials, Syringes, Bulk or Pre-Cleaned/Sterilized, Stoppers, etc…)
• Aseptic Filling (Annex 1)
• Isolation Technology
• Containers Capping & Sealing
• Containers Integrity & Particles Testing
• Labelling
• Cosmetics Defects Inspection
• Device Assembly & Inspection
• Packaging & Inspection
• Out of Place Cleaning Process
• In Place Cleaning Process
• Out of Place Sterilization Process
• In Place Sterilization Process
• Cleaning Validation Process
• Sterilization Validation Process
• Waste Handling Technologies & Systems
• Gowning Requirements
• Materials, People & Waste Flows

Qualifications:

Education:

A minimum of a Bachelor's engineering degree is required, Master's/MBA/PhD is preferred.

Required:

• A minimum of 15 years of manufacturing, project engineering, supply chain and capital project execution in the Bio-Pharmaceutical industry is required.
• Hands on experience designing, constructing, commissioning or qualifying manufacturing process equipment is required.
• Strong Bio-Pharmaceutical Drug Substance and Drug Product process engineering expertise is required, including deep experience in Annex 1.
• Large capital project management experience over $250 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.

Johnson & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers .Internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Agile Decision Making, Budget Management, Business Planning, Collaborating, Customer Centricity, Developing Others, Financial Competence, Inclusive Leadership, Leadership, Lean Supply Chain Management, Organizational Project Management, Project Engineering, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Science, Technology, Engineering, and Math (STEM) Application, Scientific Research, Stakeholder Engagement