Biopharma Process Equipment Engineer | GMP & Qualification

Infotree Global Solutions; Thousand Oaks (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Infotree Global Solutions is seeking an engineer to own biopharmaceutical process equipment, drive improvements, and coordinate maintenance and validation activities. The role includes supporting commissioning, qualification, and interactions with inspectors to ensure compliant operations.

You will monitor performance, lead root-cause analyses, and support new product introductions and technology transfers while aligning with SOPs and regulatory requirements.

Qualifications

• Master’s degree and 1 year of Engineering experience; OR Bachelor’s degree and 2 years of Engineering experience; OR Associate’s degree and 8 years of Engineering experience; OR High school diploma/GED and 10 years of Engineering experience.
• Bachelor’s degree in Chemical or Mechanical Engineering preferred.
• 4+ years of relevant work experience, including 2+ years in a biopharmaceutical operations/manufacturing environment.
• Experience in regulated environments (e.g., cGMP, OSHA, EPA) and familiarity with GMP quality systems and processes such as change control, non-conformances, corrective and preventive actions, and qualification/validation.
• Direct knowledge of GMP biopharmaceutical production facility equipment and systems, including continuous fill lines and related equipment and systems like autoclaves, CIP, washers, WFI.

Responsibilities

• Provide system ownership for biopharmaceutical process equipment and lead improvements or upgrades.
• Coordinate maintenance activities to ensure peak system performance.
• Ensure commissioning and qualification of systems and interaction with inspectors.
• Monitor systems for performance risks and implement risk-reduction strategies.
• Troubleshoot and resolve technical issues to minimize downtime; perform RCA and CAPA where needed.
• Support new product introductions by performing engineering assessments and implementing equipment modifications.
• Ensure regional medical activities align with established SOPs.

Skills

Problem-Solving

Data-Driven Engineering

Troubleshooting

Cross-Functional Collaboration

Adaptability

Education

Master’s degree in Engineering

Bachelor’s degree in Engineering

Associate’s degree with 8 years experience

High school diploma/GED with 10 years experience

Job description

Infotree Global Solutions is seeking an engineer to own biopharmaceutical process equipment, drive improvements, and coordinate maintenance and validation activities. The role includes supporting commissioning, qualification, and interactions with inspectors to ensure compliant operations.

You will monitor performance, lead root-cause analyses, and support new product introductions and technology transfers while aligning with SOPs and regulatory requirements.