Process Development Engineer (m/w - 100%)

  • Type de contrat Permanent Position - bis auf weiteres
  • Lieu
  • Référence 109818-101-1
  • Date d'entrée asap
  • Secteur Technical & Engineering
  • Date de publication 31.07.2020
  • Postuler

For our client, a Medical Device company, we are currently loking for a Process Development Engineer to reinforce its Product Process Development Team.

Process Development Engineer (m/w - 100%)

Votre mission

Work within product development team to develop manufacturing process for new products or processes :

- Define by data analysis or DOE optimized process parameters influencing product properties and then define recipes for processes such as but not limited to sterilization.
- Define heat treatment processes (part of sterilization cycle) allowing to guarantee product properties.
- Define strategy and execute initial validations of the special processes (sterilization)
- Development of manufacturing processes and scale-ups
- Define process parameters
- Define predictive models on process parameters to reach product performances
- Execute process development project tasks are accomplished within defined timelines, procedures, objectives, budget and required safety/compliance standards
- Research, develop and evaluate materials, processes and/or equipment
- Conduct feasibility studies to verify capability and functionality
- Participation on communication with notified body or agency?s
- Participation on assessments to evaluate processes changes or deviation on product performances
- Write and execute test procedures and SOPs
- Maintain complete and thorough documentation in accordance with required US and international standards (e.g., ISO compliance, GLP/GMP/QSR requirements, etc.) for assigned projects.
- Write and perform Validation plan strategy and process validations in collaboration with Validation team including methods for inspection.
- Manage and control Risk process analysis and appropriate recommendations to mitigate the risk.

Votre profil

- Engineering degree or equivalent. Combination of education and experience will be considered
- Trained to ISO 17665 - Knowledge of moist-heat sterilization
- Knowledge of ISO 13485 and GMP
- At least 4-5 years confirmed experience in product development activities and project management in a regulated field
- At least 4-5 years of relevant experience in production support/sustaining and/or process definition and development, design, scale-up, improvement and validation
- Industrial experience working in a GMP compliant setting
- Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Statistical design of experiments, process flow diagrams, device design controls, process simulation and other engineering software, etc. are preferred.
- Team player motivated by success of the company, goal-oriented, excellent communication skills, both written and oral
- Experience with regulatory filings for Medical Devices and supporting regulatory inspections
- English and French speaking

Vous reconnaissez-vous ?

Have we piqued your interest? We look forward to receiving your application!

About Manpower
Manpower Switzerland offers its customers more than 55 years of experience in the recruitment, selection and placement of permanent and temporary staff, as well as in HR solutions. Its network of 50 branches active in all linguistic regions, 20,000 temporary staff, 1,500 permanent placements and over 5,000 clients – including small, medium and large companies – in all sectors of industry make Manpower one of Switzerland’s leading providers of workforce management solutions.
Our 3 promises
“We are passionate about what we do. This passion is a motivating and driving force, ensuring excellent placement opportunities for you.”
“We care about the people we work with. Including you. That’s why our collaborations are based on trust.”
“We take on our responsibilities. For you, that means security and exciting prospects.”

I'd like to apply

Your Manpower consultant
Mathilde Augusto

Life Sciences Competence Center
Picassoplatz 4
4052 Basle

T: +41 58 307 2441

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