Manufacturing Operations Specialist
hace 3 días
At Eqval Consulting Group, Inc., we provide services to the manufacturing industry, catering to Medical Devices, Pharmaceuticals, Biotechnologies, and more. We collaborate with an exceptional group of professionals to deliver high-quality services to our clients.
Role Overview:The Manufacturing Engineer will play a key role in supporting New Products Introduction (NPI) and Process transfer activities in a regulated manufacturing environment.
Duties and Responsibilities:- Generate and execute validation protocols for new or replaced equipment, or process changes.
- Perform initial set-up, conduct troubleshooting, and continuous improvement of production equipment and processes.
- Support investigations 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.
$90,000 - $110,000 per year
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