Controls Validation Engineer - BEPC Inc. - Business Excellence Professional Consulting : Job Details

BEPC is actively looking for a Controls Validation Engineer in Irvine, CA

W2 Contract - 6 months with possible extensions!

Benefits include medical, dental, vision, and life insurance

Work Arrangement: 100% On-site

Compensation: $50.00-$55.00/hour Open depending on experience

Note: This is a W2 only role — C2C, C2H, and W2 referrals will not be considered

We are seeking a highly motivated an Electrical/Controls Engineer specializing in IT and equipment validation for cutting-edge medical device manufacturing. In this role, you will support Lifesciences Plant Operations Engineering by leading and executing validations for PLCs, SCADA systems, and other manufacturing equipment. You'll work cross-functionally with engineering, quality, validation, and regulatory teams to ensure compliance with FDA, ISO 13485, and 21 CFR Part 11 standards.

This position blends hands-on electrical and controls engineering with project leadership, supporting capital projects, process improvements, and innovation initiatives like the Factory of the Future.

Summary of Duties and Responsibilities:

Engineering & Validation

• Perform IT and electrical engineering validations for manufacturing equipment and control systems.
• Validate and troubleshoot PLCs, SCADA systems, control panels, and automation equipment.
• Integrate operational equipment with controls, automation, and other systems.
• Lead validation projects (IQ/OQ/PQ) to meet project goals and regulatory requirements.
• Execute validation protocols, document results, and prepare compliance reports.
• Diagnose connectivity issues and review PLC logic to optimize equipment performance.
• Initiate and lead the identification and ensure implementation of opportunities to optimize/improve manufacturing and/or facilities processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design new products and/or processes, etc. are up to meet standards.
• Support weekend or off-shift validation work during planned downtime.
• Perform other duties as required.

Project & Portfolio Support

• Support the capital project portfolio for Plant Operations Engineering.
• Support the work to establish complex project plans to ensure deliverables are completed to the customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
• Maintain project lists, task tracking, and schedules in Clarizen or equivalent systems.
• Serve as liaison between Microbiology, Quality, Engineering, Validation, and Regulatory Affairs.
• Record meeting notes, establish action items, and escalate issues when needed.
• Contribute to the Factory of the Future initiative as a validation and automation representative.
• Recommend technical policies and solutions aligned with project and business objectives.
• With supervisor, formulate and recommend work required to maintain systems, assets, and technical work according to project and business objectives, as needed.

Qualifications:

• Bachelor's degree in Electrical Engineering, Controls Engineering, Mechatronics, or related field.
• 5+ years of experience in electrical/controls engineering and validation in a regulated manufacturing environment (medical device preferred).
• Proficiency with PLC programming (Allen-Bradley preferred), HMI development, and SCADA systems.
• Demonstrated experience with IQ/OQ/PQ validations and FDA, ISO 13485, and 21 CFR Part 11 compliance.
• Strong troubleshooting skills for control systems, networking, and equipment connectivity.
• Candidates must reside locally in Irvine, CA

Preferred Qualifications:

• Experience managing capital project portfolios in manufacturing.
• Familiarity with Clarizen or other project management tools.
• Knowledge of risk management methodologies (FMEA, Hazard Analysis).
• Lean Six Sigma certification or process improvement training.