Johnson & Johnson
IM PD Bio-Therapeutics Technical Lead
Johnson & Johnson, New Brunswick, New Jersey, us, 08933
Overview
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). 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
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. 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 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 SeniorIty level
Not Applicable Employment type
Full-time Job function
Engineering and Information Technology Industries Referrals increase your chances of interviewing at Johnson & Johnson by 2x Get notified about new Lead Technician jobs in New Brunswick, NJ.
#J-18808-Ljbffr
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). 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
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. 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 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 SeniorIty level
Not Applicable Employment type
Full-time Job function
Engineering and Information Technology Industries Referrals increase your chances of interviewing at Johnson & Johnson by 2x Get notified about new Lead Technician jobs in New Brunswick, NJ.
#J-18808-Ljbffr