Senior Manufacturing Engineer

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 https://www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Groningen, Netherlands

Job Description:

We are Johnson & Johnson Surgical Vision Groningen, the Netherlands, and member of Johnson & Johnson's Family of Companies.

The department of Manufacturing Engineer, Asset management, is looking for a high-reaching and experienced manufacturing engineer for equipment implementation activities. As Senior Manufacturing Engineer, you will work in full collaboration with the engineering teams with focus on technology & equipment development with a strong emphasis on validation. In this role you are the authority that help deliver solutions to meet the design requirements, quality and the business targets and lead the roll out to our production lines. Support the handover to other departments by providing the adequate documentation and training.

Responsibilities:

• Implement new equipment (incl.validation) in a way that enable seamless global scaling of those equipments and processes within our organisation.
• Design, develop and implement test plans, validation documents and be accountable for the delivery and completion of those activities.
• Analyze and assess product and process requirements (materials, process, quality, EHS, product specifications) and perform risk and root cause analysis
• Develop, improve and characterize design of products, processes, equipment, test methods and procedures and define requirements
• Organize engineering, validation and verification studies by setting up a test plan and protocol, test criteria, performing tests, analyzing, interpreting and reporting outcomes as well as identifying and solving technical issues.
• Plan, organize and evaluate the implementation process of new or modified products and processes, including writing standard operating procedures (SOP’s), protocols and procedures, risk assessments and training of employees.
• Technical writing of protocols and performing validations in collaboration with Subject Matter Expert (SME))
• Gather requirements, and/or user stories, specifications and write documentation (URS, FAT, IQ OQ, PQ.) for machines & equipment including the software component.
• You are very familiar with change control in a medical device environment and are capable and comfortable in leading validation activity from the creation of CR incl. creating and execution of test protocols, writing reports of protocol outputs, up to the closure of VSR and CR.
• Communication with and support of other departments such as R&D, Quality Assurance (QA), Operations, External suppliers etc within the scope of work defined by the project.

Qualifications

Education:

• Minimal Bachelor of Science in relevant subject (E.g. Mechanical / Electrical / Engineering)

Experience and Skills:

Required:

• Minimum of 5 years of experience in a Manufacturing and/or Industrial Engineering role in medium to high volume manufacturing
• Verbal and written proficiency (at least at B2 level) in English
• Demonstrated knowledge in problem-solving methodology (DOE, Process Capability Analysis, Hypothesis Test Methods)
• Demonstrated knowledge in Design for Manufacturing (Lean Manufacturing, Tolerancing, Poka Yoke design, Theory of Constrains)
• Proficient in applying of statistical methodologies and analysis using Minitab.
• Knowledge & application experiences of GMP, GXP fundamentals
• Knowledge & application experiences of CSV fundamentals
• Hands-on mentality and strong collaboration with all teams
• Proven track record as validation SME within a medtech, pharma or other highly regulated (cGMP) sector is a must.

Desired:

• Advanced degree (MSc. or PhD) in relevant subject is desired
• Experience with metrology systems
• Experience of vision system
• Verbal and written proficiency in Dutch
• Experience of SCADA system deployment & validation
• Six Sigma Certified Green Belt / Black Belt
• Knowledge in high precision machining (lathing and milling)
• Knowledge in high precision injection molding