Senior Engineer, Facilities and Engineering

AstraZeneca•Los Angeles, CA

1d•$138,771 - $208,156•Onsite

About The Position

The Senior Engineer – Facilities & Engineering is responsible for leading and managing the technical aspects of facilities maintenance, validation processes, metrology programs, engineering projects, and capital investments within a pharmaceutical organization. This role involves providing expert technical guidance, overseeing complex projects, and ensuring that all systems and processes meet regulatory requirements and support operational efficiency.

Requirements

Bachelor’s degree in Engineering, Facilities Management, or a related field; Master’s degree or MBA preferred.
7-10 years of experience in facilities management, validation, metrology, engineering, and capital projects, with significant experience in a pharmaceutical or regulated industry.
Extensive knowledge of GMP, FDA regulations, and other relevant compliance requirements.
Proven experience in leading complex validation processes, asset management, metrology programs, facilities management, engineering projects, and capital investments.
Strong project management skills with experience in budgeting, scheduling, and resource allocation.
Excellent analytical, problem-solving, and communication skills.
Ability to manage multiple priorities and work effectively under pressure.

Responsibilities

Lead technical teams and provide guidance on facilities maintenance, validation activities, metrology practices, engineering solutions, and capital projects.
Mentor and support junior engineers and technical staff in their professional development.
Collaborate with cross-functional teams to align engineering and project activities with organizational goals.
Oversee the maintenance and operation of company facilities, including laboratories, production areas, and administrative spaces.
Develop and implement strategies for facility improvements and upgrades to enhance operational efficiency and compliance.
Ensure facilities adhere to health, safety, and environmental regulations.
Lead 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 complex validation projects, including protocol design, execution, and reporting.
Oversee metrology programs to ensure the accuracy and reliability of measurement systems and instruments.
Develop and implement calibration, maintenance, and inspection programs for critical equipment.
Ensure metrology practices comply with industry standards and regulatory requirements.
Lead engineering projects related to the design, installation, and commissioning of systems and equipment.
Ensure engineering activities adhere to Good Manufacturing Practices (GMP) and other relevant regulations.
Develop and implement preventive and predictive maintenance programs to enhance equipment reliability.
Manage all aspects of capital projects, including facility upgrades, expansions, and new construction.
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.
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.
Ensure all facilities, systems, and processes comply with regulatory requirements and industry standards.
Develop and enforce safety protocols and emergency response plans.
Conduct regular audits and inspections to ensure compliance and address any issues promptly.
Identify and implement process improvements to enhance efficiency, reduce costs, and improve system reliability.
Stay current with industry trends, technological advancements, and regulatory changes to ensure best practices are applied.