Johnson & Johnson
Join to apply for the
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.
All Job Posting Locations: Horsham, Pennsylvania; Malvern, Pennsylvania; New Brunswick, New Jersey; Raritan, New Jersey; Titusville, New Jersey; Wilson, North Carolina.
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. 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: R-042486. 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.
Responsibilities
Keep abreast of all current industry and regulatory standards and trends, in order to ensure IM Bio-Therapeutics manufacturing plants are designed, built and commissioned to leading edge industry standards.
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
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 under 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 should contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is: $146,000–$251,850 USD.
Additional description for pay transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long‑term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: 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 Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits.
#J-18808-Ljbffr
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.
All Job Posting Locations: Horsham, Pennsylvania; Malvern, Pennsylvania; New Brunswick, New Jersey; Raritan, New Jersey; Titusville, New Jersey; Wilson, North Carolina.
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. 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: R-042486. 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.
Responsibilities
Keep abreast of all current industry and regulatory standards and trends, in order to ensure IM Bio-Therapeutics manufacturing plants are designed, built and commissioned to leading edge industry standards.
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
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 under 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 should contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is: $146,000–$251,850 USD.
Additional description for pay transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long‑term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: 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 Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits.
#J-18808-Ljbffr