Production Engineer

Overview:

The Production Engineer plays a key technical role in ensuring reliable, compliant, and efficient pharmaceutical manufacturing operations. This position supports day-to-day production, drives process optimization, and leads implementation of advanced technologies and engineering solutions to enhance aseptic filling and sterile manufacturing performance. This is a position offering a hands-on environment with opportunities to make a real impact on process excellence and product quality.

Job Responsibilities:

• Serve as the Subject Matter Expert (SME) for aseptic filling, sterile manufacturing, and supporting automation systems.

• Troubleshoot and resolve production equipment and process issues in real time to minimize downtime.

• Collaborate with cross-functional teams to implement engineering improvements, process modifications, and digital technologies.

• Lead and participate in process FMEAs to assess and mitigate risks as part of validation and continuous improvement efforts.

• Apply Good Engineering Practices (GEP) and data integrity principles to enhance manufacturing consistency and compliance.

• Evaluate and execute changes to improve equipment performance, reliability, and safety.

• Partner with equipment vendors and suppliers to define specifications and qualify new systems.

• Support preventive maintenance, calibration, and system upgrades aligned with long-term technology roadmaps.

• Contribute to lean initiatives, process control strategies, and automation enhancements to increase operational efficiency.

Job Qualifications:

• Bachelor’s degree in Engineering or Life Sciences; Mechanical, Chemical, or Electrical Engineering preferred.

• 3–5+ years of experience in pharmaceutical, biotech, or other regulated manufacturing environments.

• Strong technical knowledge of aseptic processing, fill/finish operations, and cleanroom systems.

• Proven experience troubleshooting, repairing, and optimizing manufacturing or automation equipment.

• Familiarity with cGMP requirements, process validation, and documentation standards.

• Experience using FMEA, root cause analysis, and other problem-solving methodologies.

• Understanding of instrumentation, controls, and data integrity systems within a GMP setting.

• Lean Six Sigma certification or demonstrated continuous improvement experience preferred.

• Willingness to work 3rd shift and provide flexible support for production operations.