Manufacturing Engineer - Biotech - Framingham, MA

Company Name:
POSITION: Manufacturing Engineer - Biotech - Framingham, MA
PRIMARY LOCATION: Framingham, Massachusetts
BASE SALARY: $100,000 Plus bonus
This position, with minimal guidance, leads the engineering support of the Framingham Biotech / Pharmaceutical manufacturing, maintenance and capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or concurrent engineering projects of moderate scope and complexity. Actively participate and provide input and feedback for the Company Safety Program to meet Health and Safety regulations and OSHA requirements in all duties. Function as a technical expert on equipment or systems; lead troubleshooting of operations, develop preventative maintenance procedures, and maintain engineering documentation. Routinely audit the operational performance and regulatory compliance of a large number of highly complex equipment components or systems. Lead efforts with manufacturing, process development, facilities, quality assurance and other departments in developing requirements and recommendations for system modifications. Coordinate the work of consultants, and engineering firms on development of standard design documents.
Bachelors degree in Engineering with 5 to 8 years of relevant work experience with 3+ years of experience in Bio-Pharmaceuticals; or a Masters with 3 to 8 years of relevant work experience with 2+ years of experience in Bio-Pharmaceutical
Direct experience with regulated environments (i.e. cGMP, OSHA, EPA)
General understanding of Quality Systems with general understanding and wide application of technical principle, theories, and concepts in the Biotech / Pharmaceutical field
PREFERRED: General knowledge of Commissioning and Qualification
PREFERRED: Working knowledge of pharmaceutical / biotech processes
PREFERRED: Working knowledge of specialized equipment / processes
PREFERRED: Ability to effectively interact with a variety of communication and working styles
PREFERRED: Ability to independently determine when additional internal / external resources are required to solve problems
Ability to gown and gain entry to manufacturing areas.
Required to support manufacturing operations on an on call 24/7 basis.
Problem solving and applied engineering skills
Basic technical report writing and excellent communication skills.

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