Engineer II, Manufacturing

Role Summary

As an Engineer II in Manufacturing, you will be a pivotal member of our drug substance manufacturing team. You will provide engineering technical support and troubleshooting for manufacturing equipment, ensuring smooth and efficient operations. You will actively participate in new product tech transfer activities and contribute to continuous improvement initiatives. This role may involve managing small engineering projects under supervision, collaborating with contractors and cross-functional teams to enhance existing processes. You will assist in the design, specification, and installation of new equipment, as well as modifications to existing systems, and you will execute and track validation activities related to manufacturing equipment to maintain quality and compliance.

Responsibilities

• Provide engineering technical support and troubleshooting for drug substance manufacturing equipment.
• Support new product tech transfer activities and participate in investigations.
• Collaborate with contractors and provide direction to enhance processes.
• Implement change and improve existing manufacturing processes.
• Design and develop validation protocols, focusing on equipment and automation design/modifications.
• Coordinate equipment and cleaning validation protocols for specific areas.
• Develop and support equipment commissioning and qualification activities.
• Attend FAT for new equipment systems as a validation subject matter expert.
• Maintain personal training and track goal development and compliance workflows.
• Contribute to cross-functional teams and support design and installation efforts.

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.
• Preferred: Excellent oral and written communication skills.
• Preferred: Experience in a pharmaceutical or biotech manufacturing environment.
• Preferred: Ability to work off-hours, extended shifts, and weekends as needed.
• Preferred: Demonstrated experience in managing small engineering projects.