Johnson & Johnson
IM PD Bio-Therapeutics Technical Lead
Johnson & Johnson, Horsham, Pennsylvania, United States, 19044
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 innovate across the full spectrum of healthcare solutions today to deliver breakthroughs of tomorrow. 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. 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 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.
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. 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 green field and brown field Drug Substance and Drug Product facilities. This role involves significant technical leadership responsibilities and oversees the design and creation of Facility and Equipment processes and standards to ensure a safe, compliant, and reliable transition from project build phase to start-up phase.
The Bio-Therapeutics Technical Lead keeps abreast of current industry and regulator standards to ensure IM manufacturing plants are designed, built and commissioned to leading edge standards. The role works across the project team and the end state site engineering team to ensure integration and a seamless handover from project to operations.
Responsibilities
Keep abreast of current industry and regulatory standards and trends (483s, audit reports, etc.) 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 Facility and Equipment processes and standards to ensure 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 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 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 a 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.
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, including deep experience in Annex 1.
Large capital project management experience over $250 million is required.
Able to balance multiple priorities and communicate with poise and integrity in a high-profile environment.
Must be fluent in written and spoken English.
Minimum travel of 25% domestically and internationally.
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 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 inclusive interview process. 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.
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
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 are eligible to participate in medical, dental, vision, life insurance, disability, and other benefits. This position is eligible to participate in the Company's long-term incentive program. Vacation, sick time, holidays, parental leave, and other time-off benefits apply per policy. For details, see https://www.careers.jnj.com/employee-benefits.
Seniority level Not Applicable
Employment type Full-time
Job function Engineering and Information Technology Industries: Hospitals and Health Care
Referrals increase your chances of interviewing at Johnson & Johnson by 2x
Get notified about new Lead Technician jobs in Horsham, PA.
Examples of related postings may appear below:
Primary Container & Device Technical Launch Integrator Titusville, NJ $91,000 - $147,200
Emergency Medical Technician Assistant Instructor
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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. 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 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.
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. 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 green field and brown field Drug Substance and Drug Product facilities. This role involves significant technical leadership responsibilities and oversees the design and creation of Facility and Equipment processes and standards to ensure a safe, compliant, and reliable transition from project build phase to start-up phase.
The Bio-Therapeutics Technical Lead keeps abreast of current industry and regulator standards to ensure IM manufacturing plants are designed, built and commissioned to leading edge standards. The role works across the project team and the end state site engineering team to ensure integration and a seamless handover from project to operations.
Responsibilities
Keep abreast of current industry and regulatory standards and trends (483s, audit reports, etc.) 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 Facility and Equipment processes and standards to ensure 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 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 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 a 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.
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, including deep experience in Annex 1.
Large capital project management experience over $250 million is required.
Able to balance multiple priorities and communicate with poise and integrity in a high-profile environment.
Must be fluent in written and spoken English.
Minimum travel of 25% domestically and internationally.
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 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 inclusive interview process. 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.
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
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 are eligible to participate in medical, dental, vision, life insurance, disability, and other benefits. This position is eligible to participate in the Company's long-term incentive program. Vacation, sick time, holidays, parental leave, and other time-off benefits apply per policy. For details, see https://www.careers.jnj.com/employee-benefits.
Seniority level Not Applicable
Employment type Full-time
Job function Engineering and Information Technology Industries: Hospitals and Health Care
Referrals increase your chances of interviewing at Johnson & Johnson by 2x
Get notified about new Lead Technician jobs in Horsham, PA.
Examples of related postings may appear below:
Primary Container & Device Technical Launch Integrator Titusville, NJ $91,000 - $147,200
Emergency Medical Technician Assistant Instructor
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr