Manufacturing Engineer

EQVAL Consulting Group, Inc.  is a company that provides services to the manufacturing industry ( Medical Devices, Pharmaceuticals, Biotechnologies, others ).
We work with an extraordinary group of professionals ( employees and contractors ) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service.
The Manufacturing Engineer will support New Products Introduction (NPI) and Process transfer activities in a regulated manufacturing environment.
Responsible to 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.
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).
Knowledge and skills (1-3 years) 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.
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