Sr. Manufacturing Engineer
Katalyst CRO
11 hours ago
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Job summary
Katalyst CRO in Warsaw, Poland, seeks an experienced Sr. Manufacturing Engineer to lead manufacturing engineering initiatives, validation activities, and quality documentation in a regulated setting.
Ideal candidates bring 5+ years of MedTech/Pharma experience, strong ISO 13485/GMP knowledge, and hands-on IQ/OQ/PQ execution to ensure compliant production processes across devices.
Qualifications
- Bachelor's degree in mechanical, manufacturing, biomedical engineering, or related field.
- 5+ years in manufacturing and equipment validation (MedTech, Pharma, or Healthcare Devices).
- Experience with IQ/OQ/PQ validation protocols and validation documentation.
Skills
Manufacturing engineering
Equipment validation
Quality systems
Process capability analysis
CNC knowledge
Metrology
Statistical analysis
Education
Bachelor's degree in Mechanical Engineering/Manufacturing Engineering/Biomedical Engineering
Tools
Minitab
JMP
MasterControl
ETQ
Job description
Summary
We are looking for an experienced Sr. Manufacturing Engineer with a strong background in manufacturing engineering, equipment validation, and medical device manufacturing within a regulated environment.
Requirements
- Bachelor's degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or a related field
- 5+ years of experience in manufacturing and equipment validation (MedTech, Pharma, or Healthcare Devices)
- Strong knowledge of ISO 13485, GMP, 21 CFR Part 820, and ISO 14971 risk management principles
- Hands-on experience developing and executing IQ/OQ/PQ validation protocols
- Expertise in Master Validation Plans, FMEA, CAPA, and validation documentation
- Experience with metrology, calibration, Gauge R&R, and Measurement System Analysis (MSA)
- Knowledge of CNC machines, CAM software, and basic CNC programming concepts
- Experience with statistical analysis tools such as Minitab or JMP for process capability studies
- Familiarity with Document Control and eQMS platforms such as Master Control or ETQ
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