The Process Engineer III designs, specifies and installs new equipment and provides engineering technical support and troubleshooting for all cell culture, purification and processing equipment. The incumbent would reviewvalidation protocols, supportvalidation testing and reviews final reports. In addition, they would supportthe technology transfer of new processes into the facility; provides project engineering as required for new processing equipment installations and modifications to existing equipment and have the ability tomanage medium engineering projects with little direction. This role will work with and provide some direction to contractors and participate in and lead multi-function teams to implement change and improve on existing processes.
Major responsibilities include but are not limited to:
Troubleshoots equipment systems and supports associated automation system troubleshooting efforts.
Identifies and leads equipment related projects, including technology transfers, capital projects, and modifications.
Develops and supports equipment commissioning and qualification (validation) activities.
Maintains personal training, goal development / completion, compliance workflow tracking, & progress tracking.
Bachelor's Degree with a minimum of 6 years related industry experience, or an MBA/MS with a minimum of 4 years related industry experience.
Practical knowledge and application of GMP and EMEA regulations.
SIx years' experience in pharmaceutical or biotech manufacturing environment
Competency in Delta V, MS Word, MS Excel, MS Power Point and MS Project.
Excellent oral and written communication skills.
Ability to work rotating shifts, extended shifts and weekends as needed.
All your information will be kept confidential according to EEO guidelines.