Engineer II, Manufacturing

Role Summary

Engineer II, Manufacturing – provide critical equipment support and engineering technical troubleshooting for drug substance manufacturing equipment. Manage small engineering projects with guidance, participate in cross-functional teams to implement change, and contribute to new product Tech Transfer activities and investigations. Support design, specification, and installation of new equipment and modifications to existing systems to impact quality and reliability of manufacturing operations.

Responsibilities

• Troubleshoot and identify equipment system improvements to support manufacturing operations.
• Design and develop validation protocols and provide expertise for equipment and automation modifications.
• Coordinate equipment-related projects, including technology transfers and continuous improvement initiatives.
• Develop and manage Equipment & Cleaning Validation Protocols, offering technical training and on-floor guidance.
• Lead equipment commissioning and qualification activities, ensuring project deliverables are tracked and reported.
• Attend Factory Acceptance Testing (FAT) as a validation subject matter expert and support equipment startup.
• Maintain personal training records, goal development, compliance workflow, and progress tracking.
• Support the implementation of new manufacturing processes and technology transfers.
• Investigate process or equipment failures and implement corrective changes.
• Manage and track completion timelines for compliance tasks such as change controls and deviation investigations.
• Provide validation-related support for projects and continuous improvement initiatives.

Qualifications

• Required: BS in Engineering.
• Required: 0-2 years of experience in GMP validation, manufacturing, engineering, or facilities in a pharmaceutical environment.
• Required: Knowledge of GMPs and EMEA regulations.
• Required: Experience in Cleaning and Equipment Validation Philosophy.
• Required: Experience in a pharmaceutical or biotech manufacturing environment.
• Required: Excellent oral and written communication skills.
• Required: Ability to work on-site.
• Required: Ability to work rotating shifts/on-call, extended coverage support and weekends as needed.

Skills

• Demonstrated ability to identify efficiency gaps and implement best practices.
• Experience in supporting technology transfer and continuous improvement projects.

Education

• BS in Engineering.

Additional Requirements

• On-site work; ability to work rotating shifts/on-call, extended coverage, and weekends as needed.