Senior Engineer, Primary Container, Biologics
- J&J Family Of Companies
- United, Pennsylvania
- Full Time
Discover J&J
Medicines & therapies
Medical devices & technology
Media
Contact
View saved jobs
0
English
Login
Healthcare areas
News
Investors
Careers
Our company
Search J&J.com
Home
Careers
Jobs
Senior Engineer, Primary Container, Biologics
Supply Chain Engineering
Malvern / United States of America
Senior Engineer, Primary Container, Biologics
Apply now
Save
Share job
Job title
Senior Engineer, Primary Container, Biologics
Function
Supply Chain Engineering
Sub function
Packaging Design Engineering
Category
Senior Engineer, Packaging Design Engineering (ST6)
Location
Malvern / United States of America
Date posted
May 20 2026
Requisition number
R-077305
Work pattern
Hybrid Work
This job posting is anticipated to close on May 28 2026. We may however extend this time period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.
Description
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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Supply Chain Engineering
Job Sub Function:
Packaging Design Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Malvern, Pennsylvania, United States of America
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at
We are searching for the best talent for Senior Engineer, Primary Container, Biologics in Malvern, PA.
Purpose: The Senior Engineer Primary Container, Biologics, will lead the development, selection, qualification, and lifecycle management of vial systems, pre-filled syringes, cartridges, and emerging container technologies for new biologic drug products. The role ensures all primary containers comply with global regulatory, technical, and quality standards while driving innovation and operational excellence. It is part of the global Drug Delivery Systems (DDS) Team.
You will be responsible for:
Strategic Leadership & Governance
Execute the global strategy for primary containers supporting biologics across the JJIM portfolio.
Oversee development, qualification, and lifecycle management of vial systems, pre-filled syringes, cartridges, and new container technologies.
Ensure compliance with global regulatory requirements and internal quality standards.
Partner with cross-functional teams (R D, Quality, Regulatory, Supply Chain) to align container solutions with product needs.
Lead risk assessments and mitigation strategies for container systems.
Manage vendor relationships and evaluate new technologies to enhance performance and patient safety.
Provide technical leadership and subject matter expertise for regulatory submissions and inspections.
Drive innovation and the implementation of new technologies across biologics packaging.
Drive continuous improvement and innovation in container technologies.
Technical Expertise & Development
Oversee the design, evaluation, and qualification of primary container systems including vials, pre-filled syringes, cartridges, stoppers, and seals.
Provide scientific leadership on container-closure integrity (CCI), extractables and leachables (E&L), materials compatibility, and device-drug interface requirements.
Ensure container strategies support formulation stability, manufacturability, and patient usability.
Project & Portfolio Management
Partner across CMC, Formulation, Device Engineering, Quality, and Manufacturing to drive product development programs.
Manage timelines, resources, and budgets for container-related activities.
Lead risk assessments, mitigation strategies, and governance reviews.
Regulatory & Compliance
Ensure compliance with global regulatory expectations (FDA, EMA, ICH, ISO, USP/EP/JP).
Author and review regulatory documentation for IND, IMPD, BLA, and NDA submissions.
Serve as SME during regulatory inspections and health authority interactions.
Qualifications/Requirements:
Education: Minimum of a Bachelor's Degree in Packaging Engineering, Material Science, Biomedical Engineering, Chemical Engineering, or a related field is required. Advanced degree is required.
Experience/Skills:
Minimum of 5 years of experience in biologics drug product development, packaging science, or container-closure engineering.
Proven leadership experience in pharmaceutical or biotech environments.
Demonstrated experience with commercial biologics and regulatory submissions.
Technical Skills
Expertise in CCI testing, extractables/leachables, materials compatibility, and aseptic processing.
Strong understanding of combination product regulations and CMC expectations.
Specific expertise in pre-filled syringe systems is preferred.
Leadership & Soft Skills
Strong leadership, team-building, and cross-functional collaboration skills.
Excellent communication and strategic problemsolving abilities.
Ability to manage complex portfolios with multiple competing priorities.
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 , internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
Coaching, Critical Thinking, Detail-Oriented, EHS Compliance, Engineering, Good Manufacturing Practices (GMP), Lean Supply Chain Management, Package and Labeling Regulations, Package Management, Process Improvements, Product Packaging Design, Quality Assurance (QA), Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Sustainability, Sustainable Packaging, Technologically Savvy, Validation Testing
Similar jobs
Staff Packaging Engineer: Surgical Robotics - OTTAVA
Supply Chain Engineering
Santa Clara
Save
Senior Manager, Drug Product Device Assembly and Packaging (DAP) System User
Supply Chain Manufacturing
Wilson
Save
Sr. Principal Engineer, Area System Owner (1 of 2)
Supply Chain Engineering
Wilson
Save
Careers in North America
Discover career opportunities at J&J locations in the United States and Canada.
Not ready for a new role right now?
No worries. Join our talent community and we'll reach out when we post new jobs that may match your interests and skills so you can apply when the time is right.
Locations
North America
Europe, Middle East & Africa
Asia Pacific
Latin America
Medicines & therapies
Products
Oncology
Neuroscience
Immunology
Cardiopulmonary
Medical devices & technology
Products
Cardiovascular
Orthopaedics
Surgery
Vision
About us
Our company
Medicines & therapies
Medical devices & technology
Careers
Investors
Media
Key links
Terms of use
Privacy
Cookie policy
Customize Cookie Settings
Request disability accommodation
Hiring FAQs
Employment policies
E-Verify
Recruitment fraud notice
Get in touch
Contact us
Equal Employment Opportunity Posters | GINA Supplement
Do not sell or share my personal information
Limit the use of my sensitive personal information
Johnson & Johnson and its affiliates 2026
Medicines & therapies
Medical devices & technology
Media
Contact
View saved jobs
0
English
Login
Healthcare areas
News
Investors
Careers
Our company
Search J&J.com
Home
Careers
Jobs
Senior Engineer, Primary Container, Biologics
Supply Chain Engineering
Malvern / United States of America
Senior Engineer, Primary Container, Biologics
Apply now
Save
Share job
Job title
Senior Engineer, Primary Container, Biologics
Function
Supply Chain Engineering
Sub function
Packaging Design Engineering
Category
Senior Engineer, Packaging Design Engineering (ST6)
Location
Malvern / United States of America
Date posted
May 20 2026
Requisition number
R-077305
Work pattern
Hybrid Work
This job posting is anticipated to close on May 28 2026. We may however extend this time period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.
Description
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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Supply Chain Engineering
Job Sub Function:
Packaging Design Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Malvern, Pennsylvania, United States of America
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at
We are searching for the best talent for Senior Engineer, Primary Container, Biologics in Malvern, PA.
Purpose: The Senior Engineer Primary Container, Biologics, will lead the development, selection, qualification, and lifecycle management of vial systems, pre-filled syringes, cartridges, and emerging container technologies for new biologic drug products. The role ensures all primary containers comply with global regulatory, technical, and quality standards while driving innovation and operational excellence. It is part of the global Drug Delivery Systems (DDS) Team.
You will be responsible for:
Strategic Leadership & Governance
Execute the global strategy for primary containers supporting biologics across the JJIM portfolio.
Oversee development, qualification, and lifecycle management of vial systems, pre-filled syringes, cartridges, and new container technologies.
Ensure compliance with global regulatory requirements and internal quality standards.
Partner with cross-functional teams (R D, Quality, Regulatory, Supply Chain) to align container solutions with product needs.
Lead risk assessments and mitigation strategies for container systems.
Manage vendor relationships and evaluate new technologies to enhance performance and patient safety.
Provide technical leadership and subject matter expertise for regulatory submissions and inspections.
Drive innovation and the implementation of new technologies across biologics packaging.
Drive continuous improvement and innovation in container technologies.
Technical Expertise & Development
Oversee the design, evaluation, and qualification of primary container systems including vials, pre-filled syringes, cartridges, stoppers, and seals.
Provide scientific leadership on container-closure integrity (CCI), extractables and leachables (E&L), materials compatibility, and device-drug interface requirements.
Ensure container strategies support formulation stability, manufacturability, and patient usability.
Project & Portfolio Management
Partner across CMC, Formulation, Device Engineering, Quality, and Manufacturing to drive product development programs.
Manage timelines, resources, and budgets for container-related activities.
Lead risk assessments, mitigation strategies, and governance reviews.
Regulatory & Compliance
Ensure compliance with global regulatory expectations (FDA, EMA, ICH, ISO, USP/EP/JP).
Author and review regulatory documentation for IND, IMPD, BLA, and NDA submissions.
Serve as SME during regulatory inspections and health authority interactions.
Qualifications/Requirements:
Education: Minimum of a Bachelor's Degree in Packaging Engineering, Material Science, Biomedical Engineering, Chemical Engineering, or a related field is required. Advanced degree is required.
Experience/Skills:
Minimum of 5 years of experience in biologics drug product development, packaging science, or container-closure engineering.
Proven leadership experience in pharmaceutical or biotech environments.
Demonstrated experience with commercial biologics and regulatory submissions.
Technical Skills
Expertise in CCI testing, extractables/leachables, materials compatibility, and aseptic processing.
Strong understanding of combination product regulations and CMC expectations.
Specific expertise in pre-filled syringe systems is preferred.
Leadership & Soft Skills
Strong leadership, team-building, and cross-functional collaboration skills.
Excellent communication and strategic problemsolving abilities.
Ability to manage complex portfolios with multiple competing priorities.
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 , internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
Coaching, Critical Thinking, Detail-Oriented, EHS Compliance, Engineering, Good Manufacturing Practices (GMP), Lean Supply Chain Management, Package and Labeling Regulations, Package Management, Process Improvements, Product Packaging Design, Quality Assurance (QA), Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Sustainability, Sustainable Packaging, Technologically Savvy, Validation Testing
Similar jobs
Staff Packaging Engineer: Surgical Robotics - OTTAVA
Supply Chain Engineering
Santa Clara
Save
Senior Manager, Drug Product Device Assembly and Packaging (DAP) System User
Supply Chain Manufacturing
Wilson
Save
Sr. Principal Engineer, Area System Owner (1 of 2)
Supply Chain Engineering
Wilson
Save
Careers in North America
Discover career opportunities at J&J locations in the United States and Canada.
Not ready for a new role right now?
No worries. Join our talent community and we'll reach out when we post new jobs that may match your interests and skills so you can apply when the time is right.
Locations
North America
Europe, Middle East & Africa
Asia Pacific
Latin America
Medicines & therapies
Products
Oncology
Neuroscience
Immunology
Cardiopulmonary
Medical devices & technology
Products
Cardiovascular
Orthopaedics
Surgery
Vision
About us
Our company
Medicines & therapies
Medical devices & technology
Careers
Investors
Media
Key links
Terms of use
Privacy
Cookie policy
Customize Cookie Settings
Request disability accommodation
Hiring FAQs
Employment policies
E-Verify
Recruitment fraud notice
Get in touch
Contact us
Equal Employment Opportunity Posters | GINA Supplement
Do not sell or share my personal information
Limit the use of my sensitive personal information
Johnson & Johnson and its affiliates 2026
Job ID: 522463462
Originally Posted on: 5/26/2026
Want to find more Manufacturing Engineering opportunities?
Check out the 55,554 verified Manufacturing Engineering jobs on iHireManufacturingEngineers
Similar Jobs
Sign Up for Job Alerts
