Key Responsibilities
Serve as technical owner for assigned process areas and/or supplier-site tooling and equipment used to manufacture supplied materials and components, managing lifecycle activities such as upgrades, maintenance requirements, and obsolescence mitigation.
Develop, maintain, and coordinate technical review of material and component specifications, translating product and manufacturing requirements into clear supplier requirements in collaboration with R&D and Quality.
Work directly with suppliers to resolve material and component manufacturing issues, and assess proposed changes at the supplier against internal component specifications and quality requirements.
Lead root cause investigations using structured problem-solving methodologies (5 Whys, Fishbone, 5M, etc) in alignment with J&J Non-conformity and CAPA processes.
Plan and implement equipment and process validation activities in accordance with GMP, ISO 13485, and FDA 21 CFR Part 820 requirements, including Computerized System Validation where applicable.
Collaborate cross-functionally with R&D, Quality, and Supply Chain to support technology transfer and automation initiatives and to ensure Design for Manufacturability and Assembly (DFMA).
Foster a culture of innovation, safety, and continuous improvement across the manufacturing organization.
Qualifications
Education
BSc or MSc in Material Science, Mechanical, Electrical, Industrial, or related engineering field.
Experience and Skills
Minimum 2 years’ experience in manufacturing or industrial engineering within a regulated industry (Medical Device or Pharmaceutical).
Understanding of change control as well as equipment and process validation (URS, FAT, SAT, IQ, OQ, PQ, CSV).
Experience developing or maintaining material and component specifications and translating technical requirements into supplier requirements.
Experience working with suppliers on manufacturing processes, tooling, and equipment; knowledge of injection moulding is an advantage.
Working knowledge of GMP, ISO 13485, and FDA 21 CFR Part 820 requirements.
Analytical, structured, and proactive attitude with ability to handle multiple priorities.
Fluency in English and Swedish.
Required Skills
Preferred Skills
Accelerating, Communication, Detail-Oriented, Execution Focus, Facility Management, Good Manufacturing Practices (GMP), Lean Manufacturing Principles, Lean Supply Chain Management, Manufacturing Engineering, Manufacturing Science and Technology (MSAT), Problem Management, Project Engineering, Project Management Tools, Project Support, Report Writing, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy
The anticipated base pay range for this position is
kr421,000.00 - kr678,500.00
Benefits
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
