Manager / Sr. Manager Prozessentwickler/Process developer (m/w/d)
Based in Munich, our client is an international company involved in the development, production and distribution of medical devices.
Our client is currently looking for a candidate for development and implementation of manufacturing processes.
If you are looking for a new challenge and are familiar with process development, I am looking forward to our conversation.
Your tasks for this position:
- Preparation of work and testing instructions and implementation of training for production personnel
- Development and implementation of manufacturing processes for the production of complex medical devices
- Creation, detailing, implementation and documentation of state-of-the-art manufacturing and testing concepts in accordance with regulatory requirements and SOPs for sterile disposables
- Process development during the product development process with subsequent evaluation of different solution variants and economic feasibility studies in preparation for investment decisions
- Layout and process flow planning of production areas and workplaces, taking into account lean production methods and the application of GMP and GAMP-5
- Definition of criteria for the evaluation and approval of production processes
- Definition and qualification of required process equipment and measuring devices both internally and at external suppliers and development partners
- Definition of specifications for process and test method validation
- Application of statistical methods
- Preparation of process validation plans for plant qualification, process validation and test method validation
- Identification of optimisation opportunities for existing production processes and implementation of corresponding measures
- Cross-functional cooperation with the development, production and quality management departments throughout the entire product life cycle
- Determination and definition of critical process parameters as well as implementation of risk assessments and process FMEAs
What is expected
- Several years of professional experience in production process development of sterile disposables in the highly regulated working environment of medical technology
- Extensive experience in process (IQ, OQ, PQ) and software validation
- Distinct lean methods and CIP management competence
- Knowledge of plastic injection moulding in the medical technology sector
- Strong sense of responsibility, cost and quality awareness
- Convincing, communicative personality with a high degree of assertiveness and organisational talent
- Very good written and spoken German and English skills
- Analytical, structured and solution-oriented way of working
- Successfully completed studies in the field of medical technology, mechanical engineering, industrial engineering or similar
- Collaborative work style and enjoy working in cross-functional teams
Application process
- Curriculum vitae to my e-mail: p.roussos@sciproglobal.de
- Telephone call with presentation of the company
- I am your contact person for the entire application process (interviews to contract negotiations) i.e. you do not have to apply yourself
- Discussion of other exclusive positions that fit your profile
My contact details
- E-Mail: roussos@sciproglobal.de
- Tel: 0049 (0)89 / 21093938
- LinkedIn: https://www.linkedin.com/in/patrickroussos/
I am looking forward to your application!
