About The Position

The Senior Automation Controls Engineer – 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.

Requirements

  • 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.

Nice To Haves

  • Cell Therapy Experience

Responsibilities

  • 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.

Benefits

  • The annual base pay for this position ranges from $$132,900 - $199,351.
  • Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours.
  • Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
  • In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).
  • Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
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