Production Engineer I

Role Summary

The Production Engineer I – Albumin & Fractionation provides on-shift operational support for the Albumin and Fractionation departments at our Covington, GA manufacturing site. This role is critical to ensuring smooth and efficient production by rapidly resolving technical issues and enabling the team to meet manufacturing goals. As a key member of the operations team, the Production Engineer I brings technical expertise and leadership during shift operations.

Responsibilities

• Troubleshoot and timely resolve manufacturing challenges, particularly in ramp-up and steady-state operations across two automated pharmaceutical manufacturing facilities.
• Support IG Purification, Filling and Packaging, Fractionation, and Albumin Purification processes.
• Work with vessels, filtration systems, chromatography columns, UF/DF units, COP washers, CIP skids, filter presses, automatic bottle openers, centrifuges, isolators, and packaging lines.
• Operate with DeltaV, PLCs, Siemens Simatic IT, and automation hardware; perform in-process testing (pH, conductivity, titration); support safety and quality investigations.
• Drive continuous improvement by reducing manufacturing events, interventions, and batch record alerts; identify opportunities to reduce cycle time, errors, and waste; conduct operational assessments; investigate issues; support process unit team projects.
• Lead knowledge transfer sessions, coach team members, develop troubleshooting guides, and share process knowledge across shifts to promote consistency.

Qualifications

• Required: A Bachelor‚Äôs degree in an engineering discipline; prior experience in a technical or GMP-regulated environment preferred.
• Solid understanding of basic engineering principles across multiple disciplines.
• Ability to solve routine engineering problems independently and communicate technical issues clearly‚Äîboth verbally and in writing.
• Strong collaboration skills and a team-oriented mindset; self-motivated with minimal supervision.
• Exposure to Lean Manufacturing and Six Sigma methodologies is a plus.
• Willingness and ability to work 12-hour shifts, including nights, weekends, and holidays, in support of a 24/7 manufacturing operation.
• Comfortable in a clean room environment and adherence to safety protocols; ability to wear PPE as required.
• Willingness to travel occasionally (less than 5%).

Skills

• Technical problem-solving and troubleshooting
• Cross-functional collaboration and communication
• Process knowledge across purification, fractionation, and packaging
• Operational excellence and continuous improvement methodologies
• Documentation and training development

Education

• Bachelor‚Äôs degree in an engineering discipline

Additional Requirements

• Willingness to travel occasionally (less than 5%).