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. 

- Develo