Adrien Guimard is recruiting for a Senior Manufacturing Engineer to join an important project with a global Medical Device Company at their site based in Neuchatel on a contract basis until April 2022.
The main purpose of the role will be to:
- Provide day to day engineering support to the Production Department
- Propose and lead improvement projects (process, tooling)
- Support the integration of line extension projects into manufacturing
- Support capital investment requests
- Developsvalidation strategy and write validation documentation per company validation policies and regulations
- Coordinates and execute validations (SAT, FAT, IQ, OQ, PQ)
- Actively participate to Non-Conformance and CAPA process related to manufacturing• Ensure engineering activities are carried out in compliance with company policies and regulations
- Ensure all Health Safety and Environment requirements are met, and new standards are implemented
- Review weekly and monthly performance metricsto set improvement strategy and determine appropriate actions
Further responsibilities will include:
- Ensuring engineering activities are carried out in compliance with company policies and regulations
- Ensuring all Health Safety and Environment requirements are met, and new standards are implemented
- Reviewing weekly and monthly performance metrics to set improvement strategy and determine appropriate actions
In order to be considered for this role, you will be required to have thefollowing qualifications, skills and experience:
- A minimum bachelor's degree in Engineering or related technical discipline. A Master's or other advanced degree is a plus
- Technical knowledge in vacuum drying process is a plus
- A minimum of 3years of experience in Manufacturing Engineering and equipment validation is required
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability,etc
- Technical training in Project Management methodologies
- Experience working in both an FDA and European regulatory environment is preferred
- Working knowledge of GMPs, QSR, 21 CFR 820, MDD, ISO13485 and ISO14971 is required MDR is a plus• Fluency in English is required
- Fluency in French is required
Interpersonal skills / characteristics:
- Ability to Inspire and mobilize people and team
- Ability to “think out of the box”, flexibility, open-minded, team spirit and “can do”attitude are required personal skills.
- Good technical understanding of manufacturing equipment and processes is required.
- Proven evidences of multi-tasking and proven evidences of taking ownership of action outside of its direct field of responsibilities are required.
- Excellent problem solving, decision-making, and root cause analysis skills are required.
For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email firstname.lastname@example.org. Please could you send any correspondence in English. Please quote reference QLS 00050414 in all correspondence.