Validation Engineer (Med Device | GMP Quality)

LHH; Deerfield (IL); In loco; USD 80.000 - 100.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical benefits

Dental benefits

Vision benefits

Paid sick leave

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Validation

Quality Engineering

Regulatory Knowledge

Risk Management

Cross-functional Collaboration

Documentation

Descrizione del lavoro

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