Automation Engineer
2 weeks ago
Sr. Mfg Engineer, Automation
This position provides manufacturing engineering support to a Medical Device and Disposables manufacturing operation. Primary responsibilities include support of existing and new automation initiatives in the Disposable Packs Value Stream. Key Activities and Responsibilities will include but are not limited to the
following:
. Specification, installation, and qualification oftooling/equipment to
automate existing and new processes to adapt to increasing capacity
and cost constraints.
. Draft and review User Requirement Specifications (URS) for new
equipment.
. Individual project management of automation and other
tooling/equipment acquisitions/installations.
. Develop and draft associated procedures/SOP to support new
equipment installations and associated process changes.
. Perform detailed process risk assessment/mitigation for automation
and manual operations.
. Troubleshooting/repair of existing equipment, as well as providing
technical guidance to manufacturing personnel and other supporting
functions.
. Draft Packs equipment validation protocols (IQ, OQ, and PQs) to
support automation rollout.
. Execute process validations and generate validation reports.
. Evaluate existing/new IQ/OQ/PQ documentation to identify potential
gaps to the requirements and/or demonstrate traceability for
compliance.
. Draft and obtain cross-functional approval of Engineering
Rationale/Justification to close qualification gaps.
. Provide guidance to other manufacturing engineers in the evaluation,
acquisition, and implementation of automated production solutions.
No
Qualifications / Training
This position will work with internal resources including Manufacturing
Engineering, Operations, Purchasing, Supplier Quality, R&D
Engineering, Site Quality and Regulatory Affairs.
Education:
. Bachelor's degree in engineering discipline or equivalent experience.
Preferred Education:
. Bachelor's degree in mechanical, electrical, industrial, or automation
Engineering discipline.
Experience:
. Minimum of 5 years of experience in an engineering role supporting
manufacturing.
Preferred Experience:
. 3 or more years supporting medical device, medical disposables,
and/or pharmaceutical manufacturing.
Skills qualifications:
. Knowledge of the medical device industry requirements (cGMP)
. Knowledge of Quality System standards & regulations & Quality
Assurance
. Familiarity with Process Automation Integration and Qualification
. Excellent organizational, communication, and documentation skills
. Self-motivated and results-oriented individual
. Proficient in MS Office suite (Word, Excel, MS Project - Preferred)
Preferred Skills/Qualification:
. Proficient in SolidWorks
. Advanced Experience in working with Industrial Automation
. LEAN or Six Sigma training/certification9349132
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