Staff Engineer, New Process Development
On-siteSkawina, Lesser Poland, Poland
EXPIREDSkawina, Lesser Poland, PolandOn-siteFull TimeSenior LevelMasters DegreeEnterprise
Full TimeSenior LevelMasters DegreeEnterprise
Job Summary
Lead significant engineering projects for implant and instrument cleaning by implementing and installing equipment in ISO7 cleanrooms. Provide technical leadership for manufacturing operations, including equipment validation, cleanroom process flows, and developing work instructions, PFMEA, control plans, and process validation procedures. Manage supplier selection, integrate new processes with MES/SAP systems, and train operators to ensure process excellence. Requires a Master's degree, 4+ years in serial production, and proficiency in analytical tools like PFMEA and SPC. Includes 20% travel.
Required Qualifications
- Master's degree in industrial engineering, chemical engineering, or similar field
- 4+ years of experience in serial production industries
- Experience in cleanroom environments is a plus
- Proficiency in analytical tools such as PFMEA, SPC, MSA, and DoE
- Familiarity with Vision Systems, Robot programming, and advanced measuring systems
- Excellent PC skills
- Proficiency in English communication
- Experience in process validation and automation is highly desirable
- Previous experience in regulated environments based on GMP standards is advantageous
- Knowledge of NC/CAPA initiatives and engineering changes is a bonus
- Travel Percentage: 20%
- Work Flexibility: Hybrid or Onsite
Desired Qualifications
- Experience in cleanroom environments is a plus
- Experience in process validation and automation is highly desirable
- Previous experience in regulated environments based on GMP standards is advantageous
- Knowledge of NC/CAPA initiatives and engineering changes is a bonus
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