Manufacturing Engineer

Duration: 12 months

Hours:

40 hours

Imagine your next project working in full collaboration with engineering teams with focus on technology & equipment development with a strong emphasis on validation as an experienced manufacturing engineer for equipment implementation activities.

We are Johnson & Johnson Surgical Vision Groningen, the Netherlands, and the department of Manufacturing Engineer, Asset management, is looking for an experienced manufacturing engineer for equipment implementation activities. In this role you are the expert 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.

Under general or minimum supervision, performs duties in terms of stated objectives. Generally works out details within broad guidelines and exercises considerable initiative and judgment.

Roles and Responsibilities

Technical writing of protocols and performing validations in collaboration with Subject Matter Expert (SME)

Gather requirements, and/or user stories, specifications and write (URS, TM, FAT, IQ OQ, PQ.) for machines & equipment including the software component.

Will be a subject matter expert GXP, GMP & CSV as it pertains to hardware equipment solutions within the medical device arena.

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, URS, VP, etc 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 deliverables.

Implement new equipment validation in a way that enable seamless global scaling of those equipment and processes within our organisation.

Design, develop and implement test plans, validation documents and be accountable for the delivery and completion of those activities.

Qualifications

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

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

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.

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

Knowledge in high precision machining (lathing and milling)

Knowledge in high precision injection molding

This role offers a very competitive hourly rate. This contract will run for 12 months.

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