Validation Engineer

Validation Engineer

Location: Chicagoland Area (Onsite)

Job Summary

This is a full-time, onsite position located in the Chicagoland area. No contract or remote options are available.

The Validation Engineer will support computerized systems validation (CSV), manufacturing systems, and process validation activities within a regulated manufacturing environment. This role provides technical and documentation support for manufacturing processes and associated computer systems, ensuring compliance with applicable regulatory requirements, cGMP standards, and industry best practices.

The ideal candidate will possess experience with manufacturing execution systems (MES/eBR), laboratory and quality systems, data historians, and validation lifecycle documentation. This individual will collaborate cross-functionally with Quality, Manufacturing, Engineering, IT, and Regulatory groups to support validation and compliance initiatives.

Key Responsibilities

• Execute computerized system qualification activities in accordance with established procedures and validation standards.
• Coordinate testing activities with cross-functional stakeholders, evaluate results, and prepare final validation reports.
• Support validation projects involving equipment, processes, cleaning systems, utilities, computerized systems, and new product introductions.
• Develop and execute validation protocols, test scripts, and qualification documentation.
• Participate in system testing, dry runs, and user acceptance testing activities.
• Author and maintain lifecycle validation documents, including:
  • User Requirements Specifications (URS)
  • Functional Design Specifications (FDS)
  • Design Specifications (DS)
  • Risk Assessments
  • Impact Assessments
  • FMEAs
  • IQ/OQ/PQ Protocols
  • Validation Reports
• Develop and improve validation programs to maintain compliance with current regulatory expectations and industry standards.
• Support the specification, implementation, qualification, troubleshooting, and maintenance of systems, equipment, and processes.
• Participate in deviation investigations, root cause analysis, and CAPA activities.
• Author validation master plans and project validation strategies.
• Support documentation and validation activities related to MES, data historians, manufacturing applications, and supporting infrastructure.
• Provide technical support for investigations, change controls, action plans, and risk assessments.
• Contribute to continuous improvement initiatives and special projects as assigned.
• Ensure compliance with applicable quality, safety, environmental, and regulatory requirements.

Qualifications

Required

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related technical discipline.
• 1+ years of validation experience within a regulated cGMP pharmaceutical, biotech, medical device, or life sciences environment.
• Experience generating and executing IQ/OQ/PQ protocols.
• Working knowledge of CSV requirements and FDA-regulated manufacturing environments.
• Strong understanding of cGMP regulations and validation lifecycle documentation.
• Strong technical writing, communication, and problem-solving skills.
• Ability to work effectively in a cross-functional team environment.
• Proficiency with Microsoft Office applications.

Preferred

• Experience with MES/eBR systems.
• Experience with manufacturing applications, data historians, and automation systems.
• Knowledge of aseptic manufacturing, cleanroom operations, or sterilization processes.
• Experience with risk assessments, FMEA methodologies, deviations, CAPAs, and change controls.
• Project coordination or project management experience.

Core Competencies

• Strong analytical and troubleshooting skills.
• Ability to manage multiple priorities and deadlines.
• Sound judgment and decision-making abilities.
• Effective verbal and written communication skills.
• Ability to work independently with minimal supervision.
• Adaptability in a fast-paced, regulated environment.