Senior Engineer, Automation Controls – Facilities & Engineering

**Introduction to role**The Senior Engineer, Automation Controls – Facilities & Engineering is responsible for leading and managing the technical aspects of facilities and process automation/controls, including development and validation, 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 and process automation/controls, including development and validation activities, engineering solutions, and capital projects. - Mentor and support junior engineers and other technical staff in development of cross functional support for automated systems. - Collaborate with cross-functional teams to align engineering and project activities with organizational goals. ***Facilities Management:*** - As asset owner, oversee the maintenance and operation of automation/control systems and equipment within the site including critical facilities/utilities, laboratories, production areas, and administrative spaces. - Develop and implement strategies for facility automation/controls improvements and upgrades to enhance operational efficiency and compliance. - Ensure automation/controls systems adhere to health, safety, and environmental regulations. ***Validation Management:*** - Lead the development and execution of validation strategies, protocols, and documentation for site systems, equipment, and processes with focus on assets associated with automation/controls. - Ensure that validation activities meet regulatory requirements (e.g., FDA, EMA) and internal standards. - Manage complex validation projects, including protocol design, execution, and reporting. ***Automation/ Controls Oversight:*** - Oversee automation/controls programs to ensure the reliability of systems including electrical components, software environments, and automated field devices. - Develop and implement maintenance and inspection programs for critical equipment. - Ensure automation/controls engineering procedures and processes 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 automation/controls systems upgrades, expansions, and new installations. - 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 qualification/validation, engineering procedures and work instructions, and capital projects. - Generate detailed reports on project status, validation results, project activities, and asset ownership/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, company g…