Engineer III, Manufacturing

Full-time - Mid Level

NC

About the position

The Engineer III Manufacturing designs, specifies and installs new equipment and provides engineering technical support and troubleshooting for assigned process equipment and area assets. Develops validation protocols, oversees validation testing and drafts final reports. Provides project engineering as required for new processing equipment installations and modifications to existing equipment.

Responsibilities

• Support Manufacturing operations by troubleshooting issues and identifying equipment system improvements.
• Update standards, drawings and specifications as necessary.
• Identify and lead equipment related projects, including technology transfers, capital projects, and modifications.
• Complete project management tracking of deliverables for metrics & reporting.
• Provide input & guidance to Tech Transfer and project / area efforts.
• Provide technical evaluations of validation requirements for core change controls & associated action plans.
• Author sections of Validation-related reports & project plans.
• Approve Trackwise-generated workflows (deviations, global change controls) for equipment / automation-related changes.
• Review automation protocols & attend related meetings.
• Coordinate Equipment/Cleaning Validation Protocols (development, training, management, tracking).
• Specifically design & develop validation protocols.
• Provide expertise to associated equipment & automation design / modifications.
• Support FAT (Factory Acceptance Testing), equipment startup, & commissioning efforts, as required.

Requirements

• Bachelor's degree in engineering.
• Practical knowledge and application of GMP and EMA regulations.
• 2-4 years of experience in manufacturing, preferably in a pharmaceutical or biotech environment.
• Competency in Process Controls and Distributed Controls Systems.
• Proficiency in MS Word, MS Excel, MS Power Point and MS Project.
• Excellent oral and written communication skills.
• Ability to work rotating shifts, extended shifts (including weekends) and on call as needed.

Nice-to-haves

• Experience with Fill Finish, Isolator (Bausch and Stroebel) and Lyophilizer technologies.