Engineer - II

Our Manufacturing team is seeking a motivated and collaborative individual to support critical operational, equipment, and facility projects across our specialized production areas. Operating in a highly regulated GMP environment, this role sits at the intersection of technical execution and continuous improvement—supporting everything from daily on-the-floor troubleshooting to managing deviation investigations and CAPAs. The ideal candidate will be a strong problem-solver capable of examining complex technical issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to minimize downtime, ensure product safety, and drive right-first-time performance.

Responsibilities

• Support deviation management, including conducting thorough root-cause analyses, assessing potential product impact, and determining appropriate corrective/preventative actions (CAPAs).
• Author, review, update, and manage essential GMP documentation, including SOPs, batch records, change control documents, technical protocols, and validation records.
• Provide direct, on-the-floor support to resolve complex operational and technical (process/equipment) issues as they arise.
• Oversee and support technical equipment and facility projects for the Incoming Materials, Supplies Inspection, Culture Media, Weigh and Dispense Operations, and Black Widow Spider areas.
• Lead and execute continuous improvement initiatives aimed at optimizing processes, maximizing efficiency, reducing costs, and boosting overall compliance.
• Design, conduct, and review experimental protocols to evaluate and optimize process performance.
• Partner effectively with cross-functional teams, including Operations, Quality, Planning, dedicated project groups, and external vendors.
• Manage and track project timelines closely to ensure all compliance and customer due dates are met, proactively developing remediation plans for potential delays.

Education

• B.S. or B.A. in Engineering, Sciences, or a related technical discipline.

Experience

• 2 to 4 years of relevant professional experience (a combination of co-op and real-world industry experience is acceptable).
• Proven track record of strong technical writing skills alongside highly developed communication, leadership, and teamwork capabilities.
• Demonstrated ability to independently manage projects and drive tasks to completion against strict schedules and deadlines.

Additional Information

• Preferred Experience: Direct experience managing deviations and investigations within a biologics, vaccine, or bulk sterile manufacturing facility is highly desirable.
• Preferred Skills: Prior exposure to Change Control systems and regulatory compliance frameworks is a strong plus.