Validation Engineer III: Lab Instruments & Compliance Lead

SGS Consulting; Washington (District of Columbia); On-site; USD 90,000 - 130,000; Full time

Job summary

SGS Consulting is seeking a validation-focused professional to manage lifecycle activities for QC lab instruments and related software, ensuring adherence to SOPs and regulatory requirements. You will author and edit validation documents, execute IQ/OQ/PQ protocols, and support change control, deviations, and CAPA investigations.

The role requires collaboration with cross-functional teams, vendor oversight, and staying current with FDA/ISO standards.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 5–7 years of experience in validation, quality assurance, or process engineering
• Experience with validation lifecycle, IQ/OQ/PQ, and SOPs

Responsibilities

• Provide lifecycle management for Quality Control lab instruments and related software systems
• Revise and/or obsolete validation documents and SOPs
• Provide validation services for laboratory instruments and CTUs, including writing/editing/executing protocols and reviewing vendor validation documents
• Perform change control management activities, including authoring, performing, and tracking actions
• Create and perform investigations for Deviations and CAPAs
• Perform instrument periodic reviews
• Escort onsite vendors performing instrument maintenance
• Design and execute validation protocols for equipment, utilities, and processes
• Analyze test data to ensure systems meet acceptance criteria
• Document validation activities and maintain records per regulatory guidelines
• Collaborate with cross-functional teams to support product development and process improvements
• Ensure compliance with FDA, ISO, and cGMP
• Participate in audits and inspections with validation documentation and responses
• Stay current with validation trends, technologies, and regulatory updates

Skills

Analytical skills

Regulatory knowledge

Statistical analysis

Written and verbal communication

Independent work

Laboratory environment familiarity

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

Validation software

Job description

SGS Consulting is seeking a validation-focused professional to manage lifecycle activities for QC lab instruments and related software, ensuring adherence to SOPs and regulatory requirements. You will author and edit validation documents, execute IQ/OQ/PQ protocols, and support change control, deviations, and CAPA investigations.

The role requires collaboration with cross-functional teams, vendor oversight, and staying current with FDA/ISO standards.