Randstad Pharmaceutical Sr. Project Engineer in North Reading, Massachusetts
Pharmaceutical Sr. Project Engineer
location:North Reading, MA
salary:$80,000 - $95,000 per year
date posted:Tuesday, August 1, 2017
In this position, the ideal candidate will be the engineering resource responsible for independently applying advanced and diverse engineering principles to design and implement manufacturing system modifications, process improvements, maintenance projects, and capital projects associated with manufacturing operations and process utility systems. This individual will research, analyze information, and present interpretation of results for operational issues. The Sr. Process Engineer will also develop scope, lead the design and manage the implementation of capital projects of large scope and complexity.
-Responsible for leading and driving the development of engineering specifications and standards for pharmaceutical manufacturing equipment and process utility systems.
Identify root cause of failures on manufacturing and process utility systems and implement quality long term solutions.
-Demonstrate the use of problem solving skills requiring the application of engineering principles and calculations, scientific and creative methods in the development of hypotheses and approach to a large variety of technical challenges with moderate to large complexity and scope.
-Manage, coordinate and oversee development of project design documents. Select architecture and engineering firms to develop design packages. Lead project team reviews of designs/deliverables resulting in a documented progression of the project with stakeholder alignment.
-Prepare project estimates for all project related costs and manage the project against the established budget. Partner with procurement, finance and legal to prepare bid packages and construction contracts.
Working hours: 8-5
A Bachelors' Degree in an engineering field.
Minimum of 7 years' experience with Pharmaceutical/Biotech processes and systems design, engineering, commissioning, documentation, validation, maintenance, change control, and performance benchmarking of systems in a pharmaceutical / life sciences environment.
Strong understanding of Quality Systems. Solid understanding of cGMPs. Able to apply guidance documentation to implement systems aligned with current industry trends and establish best practices.
Demonstrated skills in basic technical report writing: Engineering studies, user requirement specifications, commissioning documents, etc.
Proficiency in manufacturing equipment and process utility systems design, layouts, and trade coordination.
Excellent leadership, organizational and time management skills.
Excellent oral & written communication skills. Ability to develop technical presentation materials and present.
Demonstrated working knowledge of MS Office, AutoCad, and process flow modeling software systems required.
Demonstrated expertise in the use of MS Project to plan, track and manage complex project schedules and budgets.
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