Johnson & Johnson is currently seeking a Primary Packaging Lifecycle Engineer to join our Small Molecule Drug Product Primary Container & Device Team, Manufacturing Sciences & Technology located in Beerse, Belgium, Latina, Italy and Schaffhausen, CH.
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 Med Tech, 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/.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
We, the Janssen Supply Group, LLC., are a part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as our primary focus, our group strives to provide access and affordability through innovation and strong collaboration with our R&D and Commercial partners to deliver life changing solutions for patients in need.
Are you interested in joining a team that is helping improve patient and customer care and drive innovation? Apply today!
Position Summary:
The Packaging Engineer Primary Container LCM will provide technical support for the ongoing lifecycle management of primary container closure systems, dosing devices, and critical secondary packaging materials in the Janssen Supply Chain network. The Packaging Engineer will take accountability for technical support including change control assessments, process improvements, complaint investigations, CAPA and audit support as required. The Packaging Engineer will be the key point of contact to site operations and quality leadership for their area of responsibility.
The Packaging Engineer will ensure all validation activities and ongoing production conducted at suppliers, external manufacturers and internal manufacturing sites are in compliance with all applicable procedures and to the requirements of 21 CFR Parts 3, 4,11, 210, 211 and 820 and Johnson & Johnson Policy Standards related to Good Manufacturing Practice (c GMP) for Combination Products, Pharmaceuticals, and Medical Devices.
Key Responsibilities:

• Investigates suitability of use for the packaging materials and devices for pharmaceutical products including compatibility, protection, safety, processability, etc.
• Performs root cause investigations, leads improvement plans, and writes technical documents
• Leads changes according to the change control procedure, acts as change owner, assessor or action item owner
• Introduces new techniques to the solutions of problems and makes significant contributions to improve process efficiency and quality
• Partners with external suppliers and receiving sites to ensure component development processes lead to robust manufacturing processes
• Provides technical expertise to site personnel to adequately transfer the primary packaging material for design and technology transfer activities
• Supports manufacturing process capacity scale-up for internal and external manufacturing sites
• Issues /Reviews packaging material specifications and packaging drawings

Qualifications

Education:

• Minimum of Bachelor’s in Engineering degree required; advanced degree or focused degree in Mechanical, Biomedical, or Materials Engineering is preferred

Experience and Skills:
Required:

• Minimum 2-4 years of relevant work experience
• Experience with container closure systems & packaging materials used for oral solid dosage and liquid products
• Ability to interpret engineering drawings
• Ability to use statistical techniques when analyzing data and make rational and logical decisions based on that analysis
• Ability to balance multiple priorities and operate with poise and integrity in a sophisticated and constantly evolving environment
• Strong interpersonal communication skills and ability to collaborate with external suppliers, contract manufacturers, and global partners
• Proven compliance experience with one or more of the following is required: FDA CFR part 3, 4, 210, 211, 820, or ISO 13485 (e.g., Design Control, Change Control, CAPA, and Complaint Handling)

Preferred:

• Experience in an industrial environment with primary/critical secondary packaging materials and devices
• Experience in an international environment
• Project management expertise

Other:

• Requires up to 10% domestic and international travel, including ability to work in an international environment across different time zones

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.