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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:

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** **https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Senior Engineer, Packaging Engineer to be located in Malvern, PA.

**Purpose:** The Senior Engineer within the Primary Container organization is responsible for the design, coordination, development and implementation of packaging systems for the pharmaceutical and biological businesses. This role will primarily provide support for experimental or new products, but will also support changes to primary container systems for existing or commercial products as required. This individual applies sound scientific, engineering and current regulatory knowledge for the planning and execution of development projects on a global scale. They will complete and supervise scientific studies and manage laboratory activities. The Senior Engineer will manage the development of standardized test procedures, policies, and standards for the department.

The Senior Engineer must function as a technical lead for the Primary Container group. This individual represents the department in project team meetings and works closely with other Pharmaceutical Development groups, Regulatory Affairs, Project Management, Manufacturing & Supply Chain, Quality, and Marketing to meet project timelines and objectives. They will develop and maintains a current in-depth knowledge of global regulatory submission requirements, GLP/GMP requirements (ISO 9000 where required), and maintains up to date knowledge of state- of-the-art solutions and packaging strategies though trade journals, seminars, and trade shows.

You will be responsible for:

+ Developing container closure systems, primary packaging components, and cold chain transportation systems for a variety of dosage forms and delivery systems.

+ Identifying, designing and evaluating new primary packaging concepts for eventual production use.

+ Developing and implementing package testing plans and interprets results as required for various projects; coordinate and perform activities associated with manufacturing line testing.

+ Developing packaging specifications and procedures for bulk, API, WIP, FG products including appropriate Container Closure Integrity methods and procedures.

+ Providing guidance to the Clinical organization regarding primary packaging and dosing options regarding clinical studies.

+ Supporting green packaging initiatives.

+ Maintaining ownership of primary container specifications and authoring pertinent sections of Regulatory Filings.

Qualifications / Requirements:

Education:

+ A minimum of a Bachelor's degree in Packaging, Mechanical, Chemical or Materials Engineering or a related field is required. An advanced degree is preferred.

Experience and Skills:

Required:

+ 4+ years of relevant experience is required.

+ Good oral and written communication skills, and the ability to prepare technical reports and presentations is required.

+ A team attitude with a positive outlook is a must as is the ability to work with cross-functional teams from R&D to commercial organizations is required.

+ Ability to manage multiple, complex projects is required.

+ Ability to assess technical opportunities as needed and to make appropriate recommendations to management is required.

Preferred:

+ Knowledge in the design, development, testing and commercialization of primary container systems for FDA and Global Regulated Agency products involving solid, liquid and parenteral dosage forms is preferred.

+ Experience in cold chain shipping requirements involving CRT, 2-8C, frozen and cryo products preferred.

+ Understanding of Design Controls and how they would apply to Combination products from a packaging perspective and ISO 13485 and 14971 for Risk management is preferred.

+ Experience in packaging material specifications and qualification activities including laboratory testing is preferred.

+ Demonstrated project budgeting and resource planning and management preferred.

Other:

+ This role is based in Malvern, PA and may require up to 10% domestic and international travel.

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 and 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, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

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