Experience Junior (1-3 years)
Our client, one of the world´s leading pharmaceutical company, is currently looking for their future Project Engineer.
As Project Engineer for the Product Process Development team, you will have to support new product introduction or manufacturing transfer by developing or adapting equipment’s, reducing cost and developing best practices, purchase and qualify process equipment.
- Collaborate for an effective development activity with Quality, Analytic, Validation group, and various vendors to develop and sustain solutions.
- Transform internal customers (development or manufacturing department) needs in clear URS.
- Leads all equipment qualifications activities accordingly applicable procedures and regulations.
- Write and perform Validation plan strategy and equipment qualification in collaboration with Validation team.
- Define, organize the execution or execute Verification/qualification activities (URS IQ OQ FMEA VMP).
- Provide support to new product introduction, production process development, product transfers, and existing process sustainment.
- Work cross functionally, Manufacturing and Quality to optimize processes or equipment, address yield and quality issues and drive implementation of solutions in a production environment to meet production goals (CAPA/ MRB/ DCC meetings).
- 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.
Qualifications & Experience:
- Engineering degree or equivalent, with at least 2-5 years confirmed experience in equipment installation activities and project management in a regulated field.
- Relevant experience in production support/sustaining and/or process definition and development, design, scale-up, improvement and equipment qualification.
- Industrial experience working in a GMP compliant setting.
- German –English speaking