Location(s): United States ; Massachusetts; Marlborough
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Role Summary: The Automation Qualification Engineer will help drive and lead qualification projects for Global FlexFactories as part of the Life Sciences Services Equipment Lifecycle Solutions team, initially in an Emerson DeltaV environment. Responsibilities will include the provision of technical support in the production of Qualification Plans and Qualification Protocols for process automation systems.
Leads the delivery of Qualification documentation for automation projects, both internally and with external customers, for FlexFactory and related products.
Supports the definition of standard protocols that will be used across all projects.
Establishes process automation system Qualification Plans and Protocols in an Emerson DeltaV environment in order to determine compliance with functional and cGMP requirements.
Provides assistance with the development of unit operation testing of automation elements within GE equipment.
Quality Specific Goals:
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
Complete all planned Quality & Compliance training within the defined deadlines.
Identify and report any quality or compliance concerns and take immediate corrective action as required.
Bachelor’s Degree in Electrical/Electronic or Computer Engineering, Computer Science, or in “STEM” Majors (Science, Technology, Engineering and Math).
2+ years of technical experience in pharmaceutical or equivalent automated process industries
Demonstrated experience in Emerson DeltaV Process Automation Systems
Must be willing to travel (<20%)
Self-starter, energizing, results oriented and able to multi-task
Excellent teamwork, coordination and communication skills
Ability to meet aggressive delivery targets
Effective oral and written communication skills
Experience with regulated industries (GMP, GAMP)
Locations: United States ; Massachusetts; Marlborough
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