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.

• 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…