Manufacturing Engineer / validation process engineer
cGxPServeGainesville, Florida, USAjob_description.job_card.variable_days_ago
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job_description.job_card.job_descriptionBachelors or masters degree in mechanical engineering Biomedical Engineering or related field. 5 years of experience in medical device manufacturing with hands-on experience in CNC Machining and DCM. Strong understanding of FDA ISO 13485 and GMP requirements. Proficiency in statistical analysis tools (e.g. Minitab JMP). Experience with QMS systems and documentation practices. Excellent analytical problem-solving and communication skills.
Responsibilities :
- Protocol Review & Compliance : Study and assess Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) protocols and reports for regulatory and procedural compliance.
- Process Audits & Documentation : Conduct thorough audits of manufacturing processes to identify documentation gaps. Update Quality Management System (QMS) documents to reflect findings and ensure alignment with current standards.
- Process Optimization : Design and execute Design of Experiments (DoE) to optimize process parameters for CNC Machining and DCM. Establish and document robust process parameters and operating windows.
- Validation Execution : Execute or re-execute validation protocols including sample measurements and data collection. Generate comprehensive IQ OQ PQ reports based on validation activities.
- Statistical Analysis : Run statistical reports to analyze process capability variability and performance trends.
- Change Management : Lead and document change management activities related to process improvements and equipment modifications.
- Continuous Monitoring : Monitor validated process parameters to ensure equipment and processes remain in a validated state. Implement controls and corrective actions as needed to maintain compliance.
Requirements :
Key Skills
Python,SOC,Debugging,C / C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing
Employment Type : Full-time
Experience : years
Vacancy : 1
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Validation Engineer • Gainesville, Florida, USA