Manufacturing Process Specialist
hace 2 semanas
We are seeking a highly motivated Manufacturing Process Specialist to support our New Products Introduction (NPI) and Process transfer activities in a regulated manufacturing environment at Eqval Consulting Group, Inc.
Key Responsibilities:- Generate and execute validation protocols for new or replaced equipment, or process changes
- Perform initial set-up, conduct and/or support troubleshooting, including continuous improvement, of production equipment and processes
- Support investigations process (NCRs, Complaints) and teams with Manufacturing and QA personnel for review and disposition of investigations on time
- Bachelor Degree in an Engineering Field
- 3+ years of knowledge and experience in cGMP in a Medical Devices manufacturing environment
- 3+ years of equipment qualification and process validation knowledge (IQ, OQ, PQ protocols generation and execution, deviations and reports generation)
- 3+ years of statistical analysis (GR&R) and data management (including the usage of statistical tools, i.e, Minitab)
- Knowledge and skills in diverse areas such as: Investigations (NCRs, Complaints, CAPA), Lean Manufacturing and Six Sigma Tools
- Knowledge with pFMEA (analysis and development)
- Highly Motivated, Self Starter and Multi Task Oriented
- Computer literate (Word, Excel, Power Point, Minitab)
- Excellent communicator (spoken, written) in both, English and Spanish
- EIT or PE license
$120,000 - $150,000 per year
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Manufacturing Process Specialist
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