Sr QA Process Engineer - Katalyst Healthcares & Life Sciences

• Insight Global is looking for a Senior 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 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.

Requirements:

• 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.