Engineer – GMP Drug Product Manufacturing Equipment & Reliability - (JP16085)
About The Position
The Engineer will join the Facilities & Engineering group within the Manufacturing and Clinical Supply organization, supporting drug product supply at the Thousand Oaks, California site. The group enables the introduction and integration of new technologies while ensuring clinical and commercial facilities and equipment operate reliably. This position reports to the Senior Manager of Engineering. The role provides system ownership for biopharmaceutical process equipment and supports equipment reliability, troubleshooting, maintenance, upgrades, commissioning, qualification, and validation. The Engineer identifies and leads or supports equipment and facility improvements, including developing business cases and design requirements and supporting construction and startup. The position also supports new product and technology introductions, engineering assessments, equipment modifications, and engineering runs. This is a consulting engagement with an initial duration of 1+ year, with likely extensions and/or conversion to permanent. It is fully onsite in Thousand Oaks, California. The schedule is four 10-hour shifts per week, with at least one weekend day; stated standard hours are 8:00 AM to 7:00 PM local time. Pay is $41–$46 per hour W2.
Requirements
- Doctorate degree; or 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.
- Engineering background and ability to perform and coordinate complex troubleshooting.
- Ability to work a four-day, 10-hour-per-day schedule that includes at least one weekend day.
- Ability to operate independently, adapt quickly, and learn effectively in a fast-paced environment.
Nice To Haves
- Bachelor's degree in Chemical or Mechanical Engineering.
- At least 4 years of relevant work experience, including at least 2 years in a biopharmaceutical operations or manufacturing environment.
- Experience in a regulated environment such as cGMP, OSHA, or EPA, and familiarity with GMP quality systems and processes, including change control, non-conformances, corrective and preventive actions, and qualification/validation.
- Direct knowledge of design and troubleshooting for GMP biopharmaceutical production facility equipment and systems, such as continuous fill lines (washer, tunnel, isolator, cappers, and lyophilization), filling, lyophilization, inspection, autoclaves, clean-in-place systems, washers, clean steam, and water for injection.
- Ability to analyze problems and develop and propose engineering solutions using scientific, data-driven techniques and analyses, such as root cause analysis, statistical process control, Six Sigma, and predictive maintenance.
- Experience applying engineering principles to system modifications, new process introductions, and capital project execution.
Responsibilities
- Provide system ownership for biopharmaceutical process equipment.
- Identify, support, and/or lead engineering-based improvements or upgrades to equipment and facility systems.
- Develop business cases and identify design requirements for improvements; translate requirements into process equipment or system designs and specifications, and support construction, startup, and validation.
- Direct and coordinate equipment maintenance to ensure systems operate at peak capacity.
- Ensure commissioning and qualification of systems are completed and interact with inspectors as needed.
- Monitor systems for performance risks and implement risk-reduction strategies.
- Troubleshoot issues to support production and reduce downtime, including leading or supporting technical root cause analysis and corrective/preventive action implementation.
- Support new product and technology introductions through engineering assessments, equipment modifications, and 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.
- Ensure regional medical activities align with practices, policies, and standard operating procedures.
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What This Job Offers
Career Level
Mid Level
Education Level
High school or GED
