• 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. 

• 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 qualification/validation, facilities engineering, and capital projects. Significant experience in a pharmaceutical or regulated industry is preferred. 

• Extensive knowledge of GMP, FDA regulations, and other relevant compliance requirements. 

• Proven experience in leading complex automation/controls processes, asset ownership, 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. 
   

Working Conditions: 

• 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.