Senior Engineer – Facilities & Engineering

Introduction to role

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.

Accountabilities

Leadership and Oversight:

- 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.

Facilities Management:

- 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.

Validation Management:

- 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.

Metrology Oversight:

- 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.

Engineering Leadership:

- 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.

Capital Projects Management:

- 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.

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 regular audits and inspections to ensure compliance and address any issues promptly.

Continuous Improvement: 

- 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.

Essential Skills/Experience

- 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.

- Office and on-site facilities environment, with occasional travel to various company sites or off-site locations.

- May require occasional evening or weekend work to address urgent issues or project needs.

Desirable Skills/Experience

- Cell Therapy Experience

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca is a place where every day brings new challenges. We lead from the front to ensure everyone's voice is heard on site while building trust and respect with our teams. Our adaptable nature allows us to draw on diverse expertise across functions to overcome obstacles. We champion ideas from anyone on our site with a drive to see things through. Our supportive team environment ensures we succeed together by looking out for each other. With opportunities for growth beyond your role in a stable company committed to eliminating emissions by 2025, AstraZeneca is where you can make a real impact.

Ready to take on this exciting challenge? Apply now!

The annual base pay for this position ranges from $$132,900 - $199,351. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.