Principal Packaging Cold Chain Engineer.

Job content

Janssen Supply Chain (JSC) part of the Johnson & Johnson Family of Companies is recruiting for a Principal Packaging Cold Chain Engineer to be part of the Device and Packaging COE, Technical Operations group. The preferred location for this role is Titusville, NJ, however, other locations include Latina, Italy, Schaffhausen, Switzerland, or Gurabo, Puerto Rico.

At Johnson & Johnson, we blend heart, science, and ingenuity to profoundly change the trajectory of health for humanity. This aspiration includes positively impacting patients and all others who use our products, as well as the health of our employees, our communities, and the planet.

Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provide access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.

The Principal Packaging Cold Chain Engineer will be responsible for providing temperature control / cold chain qualification & distribution study related SME support to Janssen Supply Chain (JSC). In this position, the Principal Packaging Cold Chain Engineer will work with cross functional teams to support, develop, test, qualify, leverage, and commercialize passive solutions (including Cryo shipping solutions) for both new and existing products, while working in compliance with relevant industry standards, regulations and JSC guidelines. In addition, he/she will collaborate with packaging sites (internal & external JSC sites) to support Packaging engineering related activities for LCM, new product launches and technical transfer projects.

Main Responsibilities

• Provide SME support for the design, development, testing, qualification, and commercialization of passive solutions for all JSC products, (for all cold chain / temp control products)
• Lead and assist with the execution of controlled temperature packaging qualifications and author technical protocols and reports.
• Partner with our R&D & Deliver organizations to develop temp control leveraging documents to support new product & tech-transfer activities.
• Collaborate with vendors & academia to develop new technologies for temp control related passive solutions
• Perform packaging distribution/transportation testing for new & marketed products.
• Support the supply chain with cold chain / temp control related quality / compliance investigations and CAPA activities
• Provide SME support for Shipping Route Verification related activities
• Collaborate with our R&D & Deliver organizations to establish a strong cold chain / temp control strategy and global standards to support marketed products and future product introductions.
• Develop a working knowledge of regulatory and compendial requirements to better understand cold chain requirements for commercialization and LCM activities
• Provide packaging engineering support for LCM, Tech-Transfer and New Product Launch (including rapid and ROW launches) activities.
• Responsible for the execution of global change control processes in conformance to current standards and procedures, using applicable system application tools (e.g., TrackWise, etc.). Promotes alignment between local and global processes. Ensures appropriate risk management strategies and continuity of supply prioritization.
• Partner with Regulatory Affairs, Commercial & the Artwork CoE groups to incorporate on time implementation copy and legal content to package labeling.
• Author, review & approve packaging related documentations (i.e., packaging component specifications, Packaging Bills of Materials, Packaging component drawings, Global Standards, risk/criticality assessment and procedures for bulk/finished drug products)
• Review existing and develop new cold chain related procedures to assure compliance with GMP’s and adherence to company and regulatory requirements
• Identify and deliver cost improvement or cost avoidance projects that result in lower unit cost
• Participates in risk remediation/reduction and drive toward root cause and robust corrective action/preventative action to improve process reliability.
• Manage packaging changes and brand extensions with JSC, J&J affiliates, and contract manufacturers. Establish and maintain a high level of competence while implementing innovative solutions to establish world class standards at contractor facilities.
• Support with sustainability / environmentally friendly cold chain & packaging initiatives
• Perform continuous cold chain & packaging related improvement and support sustaining efforts
  
  

Qualifications

Education:

• A minimum of a Bachelor’s degree in Packaging Engineering or Equivalent Technical / Engineering discipline is required.
  
  

Required Skills & Experience

• A minimum of seven (7) years of related experience in cold chain, packaging, labeling, and manufacturing processes
• Knowledge in the design, development, testing, qualification, and commercialization of Passive Solutions
• Experience with Primary, secondary & tertiary packaging materials & designs (i.e., bottles, caps, vials, cartons, inserts, preformed pouches, preformed trays, roll stock materials and/or form fill seal sterile barrier packaging designs, and various printing technologies)
• Knowledge of packaging distribution / transportation testing (for cold chain & non- clod chain products)
• Knowledge of cGMP
• Project management skills
• The ability to be effective in a global environment with the ability to manage and lead technical issues with Cross Functional global partners
  
  

Preferred Skills & Experience

• Validation / qualification of packaging equipment, material & processes
• Experience in the areas of pharma, chemical, biologics, medical device, or other regulated products areas
• Working familiarity with recycling packaging / shipping materials and design for the environment (Johnson & Johnson WW EHS Earthwards Tool)
• Ability to lead and influence others in a complex matrix organization
• Ability to communicate clearly and concisely across all levels of the company, across the supply chain, deliver and with the commercial franchises as appropriate
• Project Management (PMP), Lean Six Sigma, Process Excellence, FPX, and Kepner Tregoe Certifications
  
  

Other

• The preferred location for this role is Titusville, NJ, however, other locations include Latina, Italy, Schaffhausen, Switzerland, or Gurabo, Puerto Rico.
• This position may require up to 30% domestic and international travel, based on business needs.
  
  

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, depending on location, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

Primary Location

United States-New Jersey-Titusville-1125 Trenton Harbourton Road

Other Locations

Europe/Middle East/Africa-Italy-Lazio-Latina, North America-United States-Puerto Rico-Gurabo, Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen

Organization

JANSSEN SUPPLY GROUP, LLC (6046)

Job Function

Engineering

Requisition ID

2206001273W