Production Engineer (Indianapolis)

Overview

We are seeking a Production Engineer to join our Engineering and Technical Operations team. This is a key technical role responsible for ensuring data integrity, implementing advanced digital technologies, driving process control strategies, and supporting the sites technology roadmap. The ideal candidate brings pharmaceutical and / or biologics experience, GMP manufacturing expertise, and knowledge of aseptic filling, sterile manufacturing, and engineering principles.

Our organization is building a world-class contract development and manufacturing platform for injectable drugs. The culture is rooted in service, technical excellence, and collaboration. If you are motivated by the challenge of creating new systems, improving operations, and driving better outcomes for patients and customers, we want to hear from you.

Job Responsibilities

• Resolve issues that arise during daily operations and provide timely solutions.
• Collaborate with cross-functional technical teams and site leadership to implement improvements.
• Serve as the SME (Subject Matter Expert) for filling equipment and supporting systems.
• Evaluate and optimize manufacturing instruments, equipment, and tools.
• Support and / or lead process FMEAs to identify process and product risks for validation.
• Provide technical support for manufacturing activities and apply Good Engineering Practices (GEP).
• Partner with vendors and suppliers to define requirements and review functional specifications.
• Work flexible hours to ensure production facility coverage as needed.

Job Qualifications