Senior Automation Controls Engineer – Facilities & Engineering

Senior Automation Controls Engineer – Facilities & Engineering

The Senior Automation Controls Engineer – Facilities & Engineering leads and manages the technical aspects of facilities and process automation/controls, including development and validation, engineering projects, and capital investments within a pharmaceutical organization. This role provides expert technical guidance, oversees complex projects, and ensures that all systems and processes meet regulatory requirements and support operational efficiency.

• 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.

• 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.

• 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.

• 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.

• 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 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.

• 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.

• 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, company guidance, and regulatory changes to ensure best practices are applied.

• Bachelor’s degree in Engineering, Electrical Engineering preferred, or a related engineering field;
  Master’s degree preferred.
• 7-10 years of experience in automation/controls software and equipment systems, with background in…