形容
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, MSAT CoE 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.
Janssen Supply Chain (JSC) is recruiting for a Staff Packaging Engineer to be part of the MSAT COE, in Manufacturing Science and Technologies organization.
The Staff Packaging Engineer will be responsible for providing temperature control qualification, distribution study, shipping route verification and other packaging related SME support to Janssen Supply Chain (JSC). In this position, the Staff Packaging Engineer will work with cross functional teams to lead shipping route verification activities and 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 Secondary and Tertiary 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 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
- Lead and assist with the execution of controlled temperature shipping route verification activities dialing with sending, receiving sites and carriers and author technical protocols and reports.
- Perform packaging distribution/transportation testing for new & marketed products.
- Support the supply chain with temp control related quality / shipping route verification / compliance investigations and CAPA 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 Secondary and Tertiary 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
資格
- Bachelor's degree in Packaging Engineering or Equivalent Technical / Engineering discipline is required
- A minimum of seven (5) years of related experience in cold chain, packaging, labeling, and manufacturing processes is required
- Excellent knowledge of English language
- Knowledge in the design, development, testing, qualification, and commercialization of Passive Solutions is required
- Experience with secondary & tertiary packaging materials & designs is required.
- Knowledge of packaging distribution / transportation testing (for cold chain & non- clod chain products) is required
- Knowledge of packaging shipping route verification activities for cold chain & non- clod chain products is required
- Validation / qualification of packaging equipment, material & processes is preferred.
- Experience in the areas of pharma, chemical, biologics, medical device, or other regulated products areas is preferred
- Knowledge of cGMP is required
- Working familiarity with recycling packaging / shipping materials and design for the environment (Johnson & Johnson WW EHS Earthwards Tool) is preferred
- Project management skills required
- The ability to be effective in a global environment with the ability to manage and lead technical issues with Cross Functional global partners is required
- Ability to lead and influence others in a complex matrix organization is preferred
- Ability to communicate clearly and concisely across all levels of the company, across the supply chain, deliver and with the commercial franchises as appropriate is preferred
- Project Management (PMP), Lean Six Sigma, Process Excellence, FPX, and Kepner Tregoe Certifications are preferred
Location: Latina, Schaffhausen, Beerse or Titusville.
This position may require between 20% to 30% domestic and international travel, based on business needs.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.