Boston Metro Area, MA
Execute concurrent projects of moderate scope and complexity, with minimal supervision.
Interpret and execute policies and procedures. Recommend modifications to operating policies.
Function as a technical expert on equipment or systems (RSE); lead troubleshooting of operations, develop preventative maintenance procedures, and maintain engineering documentation.
Lead efforts with manufacturing, process development, facilities, quality assurance and other departments in developing requirements and recommendations for system modifications.
Execute tasks, under the direction of project managers, to complete design, engineering, construction, commissioning, and qualification for projects within schedule and budget constraints.
Coordinate the work of consultants and engineering firms on development of standard design documents.
Develop project scopes, schedules and budgets.
Obtain and critique quotes for system/facility modifications and work with vendors to execute.
General understanding of Quality Systems.
General understanding and wide application of technical principle, theories, and concepts in the Biotech/Pharmaceutical field.
General knowledge of other related disciplines.
Demonstrated skills in the following areas:
Problem solving and applied engineering
Basic technical report writing
Working knowledge of pharmaceutical/biotech process
Experience in Bio-Pharmaceuticals Direct experience with regulated environments (i.e. cGMP, OSHA, EPA).
Working knowledge of specialized equipment/processes.
General knowledge of Commissioning and Qualification.
Effectively interact with a variety of communication and working styles.
Ability to independently determine when additional internal/external resources are required to solve problems.
BS in Mechanical or Chemical Engineering with 3-6 years experience in pharmaceutical/biopharmaceutical industry or related industry/cGMP environment. Based on level, should have demonstrated experience with manufacturing processes and equipment such as CIP systems, bioreactors, filtration skids, chromatography and lyophilization equipment, etc.