Process Engineer (Biotech/Pharma)

EXECUTIVE SUMMARY
The Process Engineer will be responsible for providing drug delivery device production innovation support to project teams industrializing combination drug delivery devices for parenteral pharmaceutical therapeutics.

The candidate has in depth experience in high volume manufacturing processes and methodologies and process development to support clinical and commercial production activities within device development programs. This includes engaging both internal partners and external manufacturing partners and component suppliers.

The Process Engineer will be responsible for, and initiate, projects within engineering areas. Including defining critical steps and resources, and developing practical and thorough solutions to complex problems. The candidate will work with limited direction and may provide guidance to and coordinate work activities of other personnel. The work is reviewed with a focus on long-term perspectives, as the candidate establishes his/her own work priorities and timelines.

QUALIFICATIONS
Education and Industry Experience
B.S, M.S, or advanced degree in Engineering, with preference for Mechanical Engineering, or the equivalent.
At least 3 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.
In depth experience in high volume manufacturing processes and methodologies, with an emphasis in plastic molding and mechanical assembly is expected.
Demonstrated success in liaising with engineering and manufacturing resources.
Experience working with control systems to be used in production and batch release.
Strong expertise with statistical handling and interpretation of data, technical report writing and reviewing.
Familiarity with risk management tools; develop FMEAs of the products and ability to assess changes, non-compliances, etc., with risk assessment methods.