Biopharma Process Equipment Engineer - RCA & Upgrades

Akraya; Thousand Oaks (CA); On-site; USD 52,000 - 59,000; Full time

Job summary

Akraya is seeking a Biopharmaceutical Equipment Engineer to oversee reliable operation and continuous improvement of manufacturing equipment in a highly regulated setting. You will lead system upgrades, troubleshoot complex issues, and drive compliance with cGMP and quality systems.

The role requires proactive monitoring, risk assessment, and collaboration with inspectors to minimize downtime and ensure manufacturing readiness.

Qualifications

• Experience in biopharmaceutical manufacturing environments.
• Strong ability to perform and coordinate complex technical troubleshooting.
• Willingness to work a flexible 4x10 shift, including one weekend day.
• Experience within highly regulated biopharmaceutical manufacturing with cGMP environments and quality systems.

Responsibilities

• Own and manage biopharmaceutical process equipment systems.
• Lead engineering improvements and upgrades for equipment and facilities.
• Coordinate equipment maintenance for optimal performance.
• Oversee commissioning, qualification, and interact with inspectors.
• Analyze system performance, identify risks, and implement mitigation strategies.

Skills

Root Cause Analysis

GMP Systems

Biopharmaceutical/Process Equipment

Commissioning & Qualification

Technical Troubleshooting

Root Cause Analysis/RCA

Statistical Process Control/SPC

Maintenance

Equipment Troubleshooting

Job description

Akraya is seeking a Biopharmaceutical Equipment Engineer to oversee reliable operation and continuous improvement of manufacturing equipment in a highly regulated setting. You will lead system upgrades, troubleshoot complex issues, and drive compliance with cGMP and quality systems.

The role requires proactive monitoring, risk assessment, and collaboration with inspectors to minimize downtime and ensure manufacturing readiness.