Manufacturing Process Engineer
Alere - Scarborough, ME

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03201

Description

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

Qualifications

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

Job

:

Engineering

Primary Location

:

United States of America-Maine-Scarborough

Organization

:

Operations/COS

Schedule

:

Full-time

Unposting Date

:

Ongoing

Alere - 19 months ago - save job - copy to clipboard - block
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