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.
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**Job Function: **
Supply Chain Engineering
**Job Sub Function: **
Packaging Design Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Schaffhausen, Switzerland
Job Description:
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 Principal Device Technical Owner, MSAT (Manufacturing Science and Technology)– Synthetics ! This position is located (onsite/hybrid) in Titusville, NJ. Alternate locations may be considered in Beerse, Belgium; Latina, Italy or Schaffhausen, Switzerland.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United States, Puerto Rico- Requisition Number: R-072257
Belgium, Italy - Requisition Number: R-073358
**Switzerland - Requisition Number: **R-073346
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Position Summary:
Our Principal Device Technical Owner will be responsible for the ongoing lifecycle engineering and technical support of the device constituent for combination products in Johnson & Johnson Innovative Medicine. This engineer will transition the responsibilities from development to manufacturing and take accountability for technical support including change control assessments, process improvements, complaint investigations, CAPA and audit support as required. This person will be the key point of contact to site operations and quality leadership for their area of responsibility.
The Principal Device Technical Owner will ensure all validation activities and ongoing production conducted at suppliers, external manufacturers and internal manufacturing and assembly 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 (cGMP) for Combination Products, Pharmaceuticals, and Medical Devices.
Key Responsibilities:
- Lead device assembly design transfer, including process and equipment qualification (IQ/OQ/PQ), validation, and commissioning activities
- Lead development of manufacturing strategy, equipment User Requirements and process Failure Mode and Effects Analysis (pFMEA)
- Lead process design and characterization studies
- Develop and qualify additional capacity for sub-assembly and assembly processes per manufacturing network strategies for the production of devices
- Support assembly sites in solving technical issues
- Lead or contribute to the improvement of processes and quality systems in support of combination products and the device constituents of combination products
- Effectively perform root cause investigations and write technical documents
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 8 years of relevant work experience
- Experience in design and development of Medical Devices, Combination Products, or packaging processes in the Medical Device, Biomedical, or Pharmaceutical industries
- Experience in equipment design, qualification, and validation
- Proven interpersonal communication skills, and ability to collaborate with external suppliers, contract manufacturers, and global partners
- Demonstrated 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:
- Knowledge in plastic injection molding or metal materials and processing technologies
- Experience in leading global project teams or certification in project management
- Experience with cleaning validations
- Strong analytical problem solving skills and knowledge in applied statistics and statistical process control
- Six Sigma Black Belt Certification
- Experience with financial analysis and business case development
Other:
- **Requires **up to 25 % domestic and international travel, including ability to work in an international environment across different time zones
Hybrid#
**Required Skills: **
Preferred Skills:
Coaching, Competitive Landscape Analysis, Critical Thinking, EHS Compliance, Engineering, Good Manufacturing Practices (GMP), Lean Supply Chain Management, Organizing, Package and Labeling Regulations, Package Management, Process Improvements, Product Packaging Design, Science, Technology, Engineering, and Math (STEM) Application, Standard Operating Procedure (SOP), Sustainability, Sustainable Packaging, Transparency Reporting, Validation Testing