Biopharma Process Equipment Engineer

Crystal Equation Corporation; Thousand Oaks (CA); On-site; USD 90,000 - 140,000; Full time

Job summary

Crystal Equation Corporation is seeking an Engineer to join the Facilities & Engineering group at Thousand Oaks. The role focuses on owning and upgrading biopharmaceutical process equipment, with maintenance leadership and compliance with GMP quality systems.

This position reports to the Senior Manager of Engineering and requires the ability to work a four-day, 10-hour schedule, including one weekend day, in a fast-paced manufacturing environment.

Qualifications

• Master’s degree in Engineering with 1 year of experience, or Bachelor’s degree with 2 years in engineering.
• Experience in biopharmaceutical operations/manufacturing environment is preferred.
• Experience with GMP quality systems (change control, non-conformances, CAPA, and qualification/validation) is preferred.

Responsibilities

• Own and upgrade biopharmaceutical process equipment; translate requirements into design, spec, and validation.
• Coordinate maintenance to keep systems at peak capacity.
• Lead commissioning and qualification activities; interact with inspectors as needed.
• Monitor performance risks and implement risk reduction strategies.
• Lead root cause analysis and CAPA implementation for downtime reduction.
• Support new product/technology introductions with engineering assessments and runs.
• Provide shift coverage on a four-day, 10-hour-per-day schedule, including at least one weekend day.
• Operate independently in a fast-paced environment.

Skills

Root Cause Analysis

Problem Solving

Six Sigma

Data-driven analysis

Capital Projects

Education

Master’s degree in Engineering

Bachelor’s degree in Engineering

Job description

Crystal Equation Corporation is seeking an Engineer to join the Facilities & Engineering group at Thousand Oaks. The role focuses on owning and upgrading biopharmaceutical process equipment, with maintenance leadership and compliance with GMP quality systems.

This position reports to the Senior Manager of Engineering and requires the ability to work a four-day, 10-hour schedule, including one weekend day, in a fast-paced manufacturing environment.