Equipment Validation Engineer

Equipment Validation Engineer
Greater Chicagoland Area - Onsite
6+ Month Contract (Strong Potential for Extensions)

Automated Systems, Inc. is seeking a highly skilled Equipment Validation Engineerto support one of our leading pharmaceutical manufacturing clients in the Greater Chicagoland Area. This role is ideal for a driven quality and validation professional who enjoys tackling complex challenges, optimizing systems, and ensuring products and processes meet the highest standards of safety, compliance, and performance.

In this position, you will take ownership of project planning, coordination, and execution playing a critical role in equipment validation, change controls, supplier quality, CAPA investigations, and overall quality system excellence. You’ll collaborate cross-functionally across Quality, Supply Chain, Manufacturing, and Engineering to ensure product quality and regulatory compliance at every stage.

Key Responsibilities

• Partner with the Quality Manager and cross-functional teams to drive company-wide quality objectives, enhancing product quality and operational efficiency.
• Identify and resolve system inefficiencies that contribute to quality-related costs.
• Lead and manage equipment validation activities, including protocol creation and execution (IQ/OQ/PQ).
• Coordinate and oversee change control processes across assigned projects.
• Conduct and review customer complaint investigations and related corrective actions to ensure compliance with FDA, QSR, ISO, and customer requirements.
• Apply CAPA methodologies and problem-solving tools including FMEA, DOE, SPC,Cause & Effect analysis, and Flow Charts.
• Analyze statistical data to evaluate current standards and support quality improvement initiatives.
• Assess compliance of processes and outcomes against specifications, SOPs, and regulatory standards.
• Develop and review product specifications, ensuring accuracy and alignment with quality expectations.
• Plan and execute Supplier Quality evaluations, including supplier audits and performance assessments.
• Support and maintain quality agreements with assigned suppliers.
• Deliver training across internal departments on topics such as DOE, GR&R, statistics, sampling plans, and key quality principles.
• Act as a liaison with customers to clarify requirements, support audits, and ensure alignment with quality objectives.
• Assist in sustaining compliance with ISO standards and FDA QSR requirements.
• Contribute to Continuous Improvement initiatives using Six Sigma tools and methodologies.
• Perform additional duties as needed to support the Quality organization.

Education & Experience Requirements

• Bachelor’s degree in Engineering, Science, or a related field.
• 3+ years of experience in a Quality or Validation role strongly preferred.
• Experience in the Medical Device industry (ISO 13485) strongly preferred.
• Hands-on experience with equipment validation and IQ/OQ/PQ protocols is preferred.
• Prior experience in an onsite manufacturing environment is highly advantageous.
• Strong verbal and written communication skills, with the ability to clearly articulate technical information.
• Proficiency with advanced mathematical concepts and intermediate statistical analysis (SPC).
• Six Sigma training or certification preferred.
• Intermediate proficiency in Microsoft Office; SAP experience preferred.
• Ability to work independently using verbal and written instructions.
• Strong understanding of how individual responsibilities align with broader Quality objectives.

Pay: $42.50 - $53.50 per hour

Expected hours: 40.0 per week

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Referral program

Work Location: In person