Engineer – GMP Drug Product Manufacturing Equipment & Reliability (JP16083)

3 Key Consulting • Thousand Oaks, CA

5d • Onsite

About The Position

3 Key Consulting is hiring an Engineer – GMP Drug Product Manufacturing Equipment & Reliability for a contract consulting engagement with a leading global biopharmaceutical company. The role is part of the Facilities & Engineering group within the Manufacturing and Clinical Supply organization. The group enables the introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably. The position is based at the client’s Thousand Oaks, California site and reports to the Senior Manager of Engineering supporting drug product supply. The engagement is expected to last at least one year, with likely extensions and/or conversion to permanent employment.

The Engineer provides system ownership for biopharmaceutical process equipment and supports reliable operation, maintenance, improvement, commissioning, qualification, and validation. The role also supports new product and technology introductions, engineering assessments and runs, equipment modifications, and efforts to reduce production downtime. The standard schedule is 8 a.m.–5 p.m., Monday through Friday.

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 degree and 8 years of engineering experience; or high school diploma/GED and 10 years of engineering experience.
• 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.
• Technical aptitude and ability to troubleshoot equipment, read and understand technical documents, and use P&IDs and electrical drawings.
• Ability to collaborate effectively with diverse teams and adapt to provide support where needed.

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 (washers, tunnels, isolators, cappers, and lyophilization), filling, lyophilization, inspection, autoclaves, clean-in-place systems, washers, clean steam, and water for injection.
• Experience applying engineering principles to system modification design and implementation, introduction of new processes, and capital project execution.

Responsibilities

• Provide system ownership for biopharmaceutical process equipment.
• Identify, support, and/or lead engineering improvements or upgrades to equipment and facility systems, including developing business cases, identifying design requirements, translating requirements into system designs and specifications, and supporting construction, startup, and validation.
• Direct and coordinate equipment maintenance as needed to ensure systems operate at peak capacity.
• Ensure necessary commissioning and qualification of systems is completed and interact with inspectors as needed.
• Monitor systems for performance risks and implement risk-reduction strategies.
• Resolve issues to support production and reduce downtime, including leading or supporting technical root cause analysis and implementing corrective and preventive actions.
• Support new product and technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Ensure regional medical activities align with practices, policies, and standard operating procedures.

What This Job Offers

• Career Level: Mid Level
• Education Level: High school or GED