Sr. Process Engineer - Providence, United States - Katalyst HealthCares & Life Sciences

Katalyst HealthCares & Life Sciences Providence, United States

3 weeks ago

Description

Responsibilities:

3+ years of process development experience supporting ongoing optimization and improvement in a medical device environment
Must have experience designing, validating, and scaling up a cleaning process in a regulated chemical manufacturing environment
Experience leading and managing new process development initiatives from concept through execution including process documentation and process qualification
Expertise in CAD - designing & drafting
Understanding of cGxP principles, ISO 13485, ISO 14971, and 21CFR820
BS or MS in Polymer Science, Polymer Engineering, Chemistry or Chemical Engineering
Six-Sigma Green Belt

Requirements:

Insight Global is looking for a Senior Process Engineer to sit on site in Providence, RI at one of the top pharmaceutical companies in the country.
The position is fully on-site, M-F 9-5, reporting to the Senior Manager of Process Engineering.
This role will focus on process development, optimization and scale-up for clinical manufacturing.
A successful candidate for this role will have a strong track record in process development engineering in a medical device space, having led initiatives from concept through execution.
This role has a chemistry/cleaning focus as this individual must have experience designing a cleaning process, not just validating it, in a chemical manufacturing environment. Other key responsibilities include design and development of equipment, processes, and control systems, writing and reporting of protocols, reports, SOP's, and work instructions, designing 3D CAD models, and providing hands-on troubleshooting assistance.
This is an amazing opportunity for a senior engineer to get their foot in the door at a fast-paced and high growth company.

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