Johnson & Johnson
IM PD Bio-Therapeutics Technical Lead
Johnson & Johnson, Wilson, North Carolina, United States, 27893
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IM PD Bio-Therapeutics Technical Lead
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Johnson & Johnson 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 : Horsham, Pennsylvania; Malvern, Pennsylvania; New Brunswick, New Jersey; Raritan, New Jersey; Titusville, New Jersey; Wilson, North Carolina 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; Wilson, NC; 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. Apply to the postings that align with your location(s). The Applications will be considered as a single submission. In Engineering & Property Services (E&PS) we provide end-to-end services from Real Estate, Engineering & Strategic Project Delivery to Facilities Management, influencing the entire J&J Enterprise and delivering flexible site solutions. Responsibilities Keep abreast of current industry and regulatory standards and trends to ensure IM Bio-Therapeutics manufacturing plants are designed, built and commissioned to leading edge standards. Define and deploy a vision and strategy for standard Facility and Equipment design for all IM Bio-Therapeutics capital projects. Oversee design and creation of Facility and Equipment processes and standards to ensure safe, compliant, and reliable transition from project build to start-up. Develop new engineering standards for facility design for Bio-Therapeutics. Provide expert engineering technical support for green field and brown field Drug Substance and Drug Product facilities. Nurture future talent by mentoring internal and external engineers. Collaborate with the Global Engineering Technology (GET) team to ensure alignment with technology standards and project execution. Ensure compliance with policies, procedures, government regulations, and customer specifications. Proactively research and implement new standards to drive growth and efficiency. Report regularly to senior management on activities and status. Interfaces 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 a strong technical background, excellent communication skills, and a proven track record of engineering excellence to lead the development and implementation of leading-edge engineering standards across our platform. The candidate will drive innovative facility process design and ensure seamless site integration. 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. Strong Bio-Pharmaceutical Drug Substance and Drug Product process engineering expertise, including deep experience in Annex 1. Large capital project management experience over $250 million. Ability to balance multiple priorities and communicate with poise in a high-profile environment. Fluency in written and spoken English. Travel: minimum 25% domestic and international. Primary work location is a hybrid remote and in-office environment. EEO Statement 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 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. For accommodations, visit https://www.jnj.com/contact-us/careers. Salary
and
Benefits : The anticipated base pay range is $146,000 - $251,850 USD. This description also references company-sponsored benefit programs and leave policies as outlined on the Johnson & Johnson careers site. Note : This description is a refined format to meet presentation standards and remove non-essential listings and noisy content.
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IM PD Bio-Therapeutics Technical Lead
role at
Johnson & Johnson 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 : Horsham, Pennsylvania; Malvern, Pennsylvania; New Brunswick, New Jersey; Raritan, New Jersey; Titusville, New Jersey; Wilson, North Carolina 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; Wilson, NC; 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. Apply to the postings that align with your location(s). The Applications will be considered as a single submission. In Engineering & Property Services (E&PS) we provide end-to-end services from Real Estate, Engineering & Strategic Project Delivery to Facilities Management, influencing the entire J&J Enterprise and delivering flexible site solutions. Responsibilities Keep abreast of current industry and regulatory standards and trends to ensure IM Bio-Therapeutics manufacturing plants are designed, built and commissioned to leading edge standards. Define and deploy a vision and strategy for standard Facility and Equipment design for all IM Bio-Therapeutics capital projects. Oversee design and creation of Facility and Equipment processes and standards to ensure safe, compliant, and reliable transition from project build to start-up. Develop new engineering standards for facility design for Bio-Therapeutics. Provide expert engineering technical support for green field and brown field Drug Substance and Drug Product facilities. Nurture future talent by mentoring internal and external engineers. Collaborate with the Global Engineering Technology (GET) team to ensure alignment with technology standards and project execution. Ensure compliance with policies, procedures, government regulations, and customer specifications. Proactively research and implement new standards to drive growth and efficiency. Report regularly to senior management on activities and status. Interfaces 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 a strong technical background, excellent communication skills, and a proven track record of engineering excellence to lead the development and implementation of leading-edge engineering standards across our platform. The candidate will drive innovative facility process design and ensure seamless site integration. 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. Strong Bio-Pharmaceutical Drug Substance and Drug Product process engineering expertise, including deep experience in Annex 1. Large capital project management experience over $250 million. Ability to balance multiple priorities and communicate with poise in a high-profile environment. Fluency in written and spoken English. Travel: minimum 25% domestic and international. Primary work location is a hybrid remote and in-office environment. EEO Statement 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 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. For accommodations, visit https://www.jnj.com/contact-us/careers. Salary
and
Benefits : The anticipated base pay range is $146,000 - $251,850 USD. This description also references company-sponsored benefit programs and leave policies as outlined on the Johnson & Johnson careers site. Note : This description is a refined format to meet presentation standards and remove non-essential listings and noisy content.
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