Position: Maintenance Engineer, Facilities & Engineering – Biopharmaceutical Manufacturing
Location: Thousand Oaks, CA - Contract
The Engineer will be joining the Facilities & Engineering (F&E) group within the Manufacturing and Clinical Supply organization at our client's company. The group’s mission is to enable the introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably. This position will report to the Senior Manager of Engineering supporting drug product supply at the 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 the development of a 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.
• Ensure regional medical activities align with practices, policies, and standard operating procedures.
What we expect of you:
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.
Preferred Qualifications:
• 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.