Manufacturing Engineer: Process Validation and Improvement
hace 6 días
At Eqval Group, Inc., a leading provider of services to the manufacturing industry, we are seeking an experienced Manufacturing Engineer to join our team. This is a full-time, contract position with a competitive salary range of $120,000 - $160,000 per year.
Job Summary
We are looking for a highly motivated and skilled Manufacturing Engineer to support New Products Introduction (NPI) and Process transfer activities in a regulated manufacturing environment. The successful candidate will be responsible for generating and executing validation protocols for new or replaced equipment, or process changes.
The ideal candidate will have a Bachelor's Degree in an Engineering Field and 5+ years of experience in cGMP in a Medical Devices manufacturing environment. They should also possess strong knowledge and skills in equipment qualification and process validation, statistical analysis, and data management.
Key Responsibilities
- Generate and execute validation protocols for new or replaced equipment, or process changes
- Support investigations process (NCRs, Complaints) and teams with Manufacturing and QA personnel for review and disposition of investigations on time
- Perform initial set-up, conduct and/or support troubleshooting, including continuous improvement, of production equipment and processes
- Minimum Requirements:
- Bachelor Degree in an Engineering Field
- 5+ years of knowledge and experience in cGMP in a Medical Devices manufacturing environment
- 5+ years of equipment qualification and process validation knowledge (IQ, OQ, PQ protocols generation and execution, deviations and reports generation)
- 5+ years of statistical analysis (GR&R) and data management (including the usage of statistical tools, i.e, Minitab)
Benefits
- Dental insurance
- Employee assistance program
- Employee discount
- Health insurance
- Life insurance
- Paid time off
- Professional development assistance
- Referral program
Working Conditions
This is a full-time, contract position with a competitive salary range of $120,000 - $160,000 per year. The work schedule is 8 hours a day, Monday to Friday, with occasional weekends as needed. Only local candidates will be considered.
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