What are the responsibilities and job description for the Controls Validation Engineer position at BEPC, Inc.?
Job Details
Summary
Join our team as 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.
Key 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.
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
Required:
- 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.
Preferred:
- 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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
Salary : $55 - $60