Senior Engineer, Automation Controls – Facilities & Engineering
About The Position
The Senior Engineer, Automation Controls leads facilities and process automation in a pharmaceutical environment. The role drives engineering projects, validation, and capital investments while ensuring systems meet GMP and regulatory standards. It provides expert technical guidance, oversees complex projects, and enhances operational efficiency across critical facilities, laboratories, and production areas. The role leads automation and controls across facilities, engineering, and capital projects; serves as asset owner for automation and control systems; manages validation strategies and projects; and directs system design, installation, commissioning, maintenance, upgrades, and new installations. It also manages project budgets, schedules, and coordination with stakeholders and vendors; prepares and reviews technical and compliance documentation; supports audits and inspections; and implements process improvements. The work is based in an office and on-site facilities environment, with occasional travel. The company expects employees to work in the office an average of at least three days per week while respecting individual flexibility. Evening or weekend work may be required for urgent projects.
Requirements
- Bachelor’s degree in engineering or a related engineering field; Electrical Engineering is preferred.
- 7–10 years of experience in automation/controls software and equipment systems, including qualification/validation, facilities engineering, and capital projects.
- Experience in a pharmaceutical or regulated industry.
- Extensive knowledge of GMP, FDA regulations, and other relevant compliance requirements.
- Proven experience leading complex automation/controls processes, asset ownership, engineering projects, and capital investments.
- Strong project management skills, including budgeting, scheduling, and resource allocation.
- Strong problem-solving and communication skills.
- Ability to manage multiple priorities under pressure.
Nice To Haves
- Master’s degree preferred.
- Electrical Engineering preferred.
- Cell Therapy experience.
Responsibilities
- Guide technical teams in automation and controls development, validation, and engineering solutions; mentor junior staff and collaborate across functions.
- Act as asset owner for automation and control systems across critical facilities, laboratories, and production areas; develop upgrade and efficiency strategies.
- Lead validation strategies, protocols, documentation, and complex validation projects from design through reporting.
- Ensure reliability of systems, including electrical components, software, and field devices; implement maintenance and inspection programs.
- Direct system and equipment design, installation, and commissioning while ensuring GMP compliance.
- Develop preventive and predictive maintenance programs to maximize reliability.
- Manage automation and controls upgrades, expansions, and new installations, including budgets, schedules, and stakeholder and vendor coordination.
- Prepare and review validation, engineering-procedure, and capital-project documentation; generate detailed, accurate, compliant reports.
- Maintain regulatory and industry-standard compliance; enforce safety protocols and emergency response plans; conduct audits and inspections and address issues proactively.
- Identify and implement improvements to enhance efficiency, reduce costs, and improve reliability; stay current with industry and regulatory changes.
Benefits
- Qualified retirement program (401(k) plan).
- Paid vacation and holidays.
- Paid leaves.
- Health benefits, including medical, prescription drug, dental, and vision coverage.
- Short-term incentive bonus opportunity.
- Eligibility to participate in an equity-based long-term incentive program for salaried roles.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
