Responsible for all Manufacturing Equipment and equipment quality/cost savings initiatives, improving efficiency through material and process improvement, reducing material processing costs, and participating in new product design as required. Assures compliance with cGMP, quality and safety standards.
Essential Duties and Responsibilities
include the following. Other duties may be assigned.
Analyzes current "in house" raw material specifications to ensure appropriate features and limits are in place to support company manufacturing process
Evaluates company initiated raw material changes and coordinates appropriate testing and validation as required
Suggests and supports new methods or materials for continual improvement in the quality or efficiency of a product or process
Works to reduce costs in all areas of manufacturing. Analyzes current equipment for process suitability and provides detailed plans for improvement
Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to insure compliance, efficient and safe procedures
Preventative maintenance audits and compliance with SOPs, ISO, FDA and cGMP requirements
Works with other engineers and technicians in developing solutions and improvements in materials, equipment and process as necessary
Research engineering solutions to a diverse set of challenges in production and development
Other Skills and Abilities
Must be able to work on problems of diverse scope where analysis of the problem requires evaluation of obscure or unknown data
Must be able to use precision measuring equipment, hand and power tools
Must be able to meet deadlines while working on multiple projects
Familiarity with cGMP and ISO 13485 regulations and practices is desired
Experience in design/build, automation, PLC programming, equipment troubleshooting is advantageous
Experience with process development, machine logic and machine service
Working knowledge CAD
Strong technical writing skills a must
Familiarity with a variety of material testing and measuring methods
Bachelor's degree (BS) in mechanical engineering technology or mechanical engineering or equivalent combination of education and experience.
Minimum three years engineering experience in a manufacturing environment
Experience working in a GMP, FDA, ISO and USDA regulated environment preferred
United States of America-Maine-Scarborough
Alere - 2 years ago
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When you really need an answer -- fast -- toss out the crystal ball and bring in Alere. The company offers both professional and consumer...