Process Engineer – Direct Hire

📍 Carmel, IN Area

We’re partnering with a growing pharmaceutical manufacturer in the Carmel, IN area that is looking to add a Process Engineer to their team. This is a direct-hire opportunity supporting a fast-paced, highly regulated manufacturing environment focused on sterile drug product production.

This role will be heavily involved in driving process improvements, troubleshooting manufacturing and equipment issues, and supporting overall operational reliability. You’ll work cross-functionally with teams across Quality, Manufacturing, Validation, and R&D to help ensure processes are efficient, compliant, and scalable.

What you’ll be doing:

• Lead troubleshooting and root cause investigations related to manufacturing processes and equipment
• Own and support deviations, CAPAs, and change control activities
• Drive continuous improvement initiatives (Lean / Six Sigma / Operational Excellence)
• Support implementation of process and equipment improvements
• Assist with development and updates to procedures, batch records, and training materials
• Monitor process performance through data trending and reporting tools
• Partner cross-functionally to ensure compliance with GMP and regulatory standards

What they’re looking for:

• Bachelor’s degree in Engineering (Mechanical, Chemical, or related)
• 3+ years of experience in a regulated manufacturing environment (FDA/cGMP required)
• Experience with hands-on troubleshooting of production machinery and systems
• Experience with root cause analysis, deviations, and CAPA processes
• Strong understanding of quality systems, validation, and regulatory impact
• Ability to work in a fast-paced, evolving environment and collaborate across teams