Validation Engineer

LHH; Deerfield (IL); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Paid sick leave

Job summary

LHH is partnering with a confidential medical device/pharmaceutical organization in Deerfield, IL, seeking a Validation Engineer to support quality systems, regulatory compliance, and validation activities across manufacturing and product development. You will lead validations, develop protocols, and ensure systems meet regulatory standards.

The role offers exposure to end-to-end validation, CAPA, and cross-functional collaboration with Quality, Engineering, and Manufacturing teams in a

Qualifications

• 5+ years of experience in Validation / Quality Engineering within a regulated industry.
• Background in medical device or pharmaceutical environments.
• Strong knowledge of FDA regulations, ISO 13485, cGMP, and QSR requirements.
• Experience with process validation, test method validation, and calibration.
• Familiarity with design controls, risk management (ISO 14971), and quality systems.
• Strong analytical, documentation, and cross-functional communication skills.

Responsibilities

• Lead and support equipment, process, and system validations across manufacturing operations.
• Develop and execute validation protocols and performance testing for new and existing systems.
• Analyze validation data to ensure compliance with specifications and regulatory requirements.
• Maintain calibration systems, validation documentation, and equipment databases.
• Partner cross-functionally with Quality, Engineering, and Manufacturing teams.
• Support CAPA, nonconformance investigations, and root cause analysis.
• Contribute to design controls, change management, and product development quality activities.

Skills

Validation

Quality Engineering

Regulatory Knowledge

Risk Management

Cross-functional Collaboration

Documentation

Job description

We're partnering with a confidential organization in the medical device / pharmaceutical space seeking a Validation Engineer to support quality systems, regulatory compliance, and validation activities across manufacturing and product development.

This role plays a key part in ensuring equipment, processes, and systems meet strict regulatory and quality standards.

What You'll Do

• Lead and support equipment, process, and system validations across manufacturing operations
• Develop and execute validation protocols and performance testing for new and existing systems
• Analyze validation data to ensure compliance with specifications and regulatory requirements
• Maintain calibration systems, validation documentation, and equipment databases
• Partner cross-functionally with Quality, Engineering, and Manufacturing teams
• Support CAPA, nonconformance investigations, and root cause analysis
• Contribute to design controls, change management, and product development quality activities

What We're Looking For

• 5+ years of experience in Validation / Quality Engineering within a regulated industry
• Background in medical device or pharmaceutical environments
• Strong knowledge of FDA regulations, ISO 13485, cGMP, and QSR requirements
• Experience with process validation, test method validation, and calibration
• Familiarity with design controls, risk management (ISO 14971), and quality systems
• Strong analytical, documentation, and cross-functional communication skills

Why This Role?

• Direct impact on product quality, compliance, and patient safety
• Exposure to end-to-end validation and quality systems
• Opportunity to work in a regulated, high-growth environment
• Strong career growth within Quality & Regulatory functions

Compensation: $80-100k base

Benefits: Medical, dental, vision, paid sick leave where applicable by state law

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers