Engineer – Facilities and Engineering

**Engineer - Facilities and Engineering** Are you ready to engineer reliability at scale so life-changing medicines reach patients without delay? Join a team that turns robust engineering, smart investment, and disciplined execution into secure, efficient, and compliant production across a global network. In this role, you will combine project leadership, GMP expertise, and a Lean mindset to lift performance across critical assets and facilities. From shaping maintenance strategies and capital renewals to resolving deviations, you will reduce downtime, strengthen compliance, and unlock capacity that supports product launches and stable supply in fast-moving markets. This role will be based in **Tarzana, CA.** **Key Responsibilities** **Cross Functional Team Engagement:** - Engage with cross functional technical teams and provide input on facilities maintenance, validation activities, metrology practices, engineering solutions, and capital projects. - Work with senior engineers and technical staff and support major engineering initiatives via projects and standard work. - Collaborate regularly with multiple departments to align engineering and project activities with organizational goals. **Facilities Engineering:** - Oversee assigned segments of the maintenance and operation of facilities, including laboratories, manufacturing areas, and ancillary GMP spaces. - Support development and implementation of strategies for facility improvements and upgrades to enhance operational efficiency and compliance. - Ensure facilities adhere to health, safety, and environmental regulations. **Validation Activities:** - Support the development and execution of validation strategies, protocols, and documentation for systems, equipment, and processes. - Ensure that validation activities meet regulatory requirements (e.g., FDA, EMA) and internal standards. - Manage mid-size validation projects, including protocol design, execution, and reporting. **Metrology Activities:** - Support metrology programs by ensuring the accuracy and reliability of measurement systems and instruments. - Develop and implement calibration, maintenance, and inspection programs for critical equipment. - Review and revise metrology practices to ensure compliance with industry standards and regulatory requirements. **Engineering/Maintenance Projects:** - Lead mid-size corrective maintenance/engineering projects related to the design, installation, and commissioning of new or modified systems and equipment. - Ensure engineering activities adhere to Good Manufacturing Practices (GMP) and other relevant regulations. - Develop and implement preventive maintenance programs to enhance equipment reliability. Support predictive maintenance initiatives led my senior team members. **Capital Projects Management:** - Manage aspects of capital projects, including facility upgrades, expansions, and new construction, with minimal support from senior team members. - Develop project plans, budgets, and schedules; monitor progress and ensure projects are completed on time and within budget. - Coordinate with internal stakeholders, external contractors, and vendors to achieve project objectives and compliance. **Documentation and Reporting:** - Prepare and review comprehensive documentation for validation, metrology, engineering, and capital projects. - Generate detailed reports on project status, validation results, calibration activities, and maintenance work. - Ensure that documentation is accurate, complete, and compliant with regulatory requirements. **Compliance and Safety:** - Ensure all facilities, systems, and processes comply with regulatory requirements and industry standards. - Develop and enforce safety protocols and emergency response plans. - Conduct routine audits and area inspections to ensure compliance and address any issues promptly. **Continuous Improvement:** - Identify and implement process improvements to enhance efficiency, reduce costs, and improve system reliabili…