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

The Engineer will be joining Facilities & Engineering (F&E) group within the Manufacturing and Clinical Supply organization. The group’s mission is to enable introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably. This position will report into Senior Manager of Engineering supporting drug product supply at our Client's Thousand Oaks site.

Responsibilities

• Provide system ownership for Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
• Directing and coordinating equipment maintenance as necessary to ensure systems are working at peak capacity.
• Ensure necessary commissioning and qualification of systems is completed and interact with inspectors as necessary.
• Monitor systems to identify performance risks and implement risk reduction strategies.
• Solving issues to support and reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Provide shift coverage on a four-day, 10-hour-per-day schedule, including at least one weekend day.
• Operate independently, adapt quickly, and learn effectively in a fast-paced environment

Required Skills

• Master’s degree and 1 years of Engineering experience Or
• Bachelor’s degree and 2 years of Engineering experience

Preferred Skills

• Bachelor’s degree in Chemical or Mechanical Engineering
• 4+ years' of relevant work experience with 2+ years' experience in Biopharmaceutical operations/manufacturing environment
• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as continuous fill lines (washer, tunnel, isolator, cappers and lyophilization), filling, lyophilization, inspection, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
• Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects