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 .
  • S ignificant 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

  • 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, o versee the maintenance and operation of automat ion /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 automat ion /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 guidance, and regulatory changes to ensure best practices are applied.

Benefits

  • qualified retirement program [401(k) plan]
  • paid vacation and holidays
  • paid leaves
  • health benefits including medical, prescription drug, dental, and vision coverage
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