Validation Engineer - III

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

Job Responsibilities

• Provide lifecycle management for Quality Control lab instruments and related software systems
• Revise and/or obsolete validation documents and Standard Operating Procedures (SOPs)
• Provide validation services for laboratory analytical instruments and controlled temperature units (CTU), including writing, editing, executing protocols, and reviewing vendor validation documents in accordance with site validation requirements
• Perform change control management activities, including authoring, performing, and tracking change actions
• Create and perform investigations for Deviations and CAPAs
• Perform instrument periodic reviews
• Escort onsite vendors performing laboratory instrument maintenance
• Design and execute validation protocols (IQ/OQ/PQ) for equipment, utilities, and processes
• Analyze test data and determine whether systems meet predefined acceptance criteria
• Document validation activities and maintain records in accordance with regulatory guidelines
• Collaborate with cross-functional teams to support product development and process improvements
• Ensure compliance with industry standards such as FDA, ISO, and cGMP
• Participate in audits and inspections, providing validation documentation and responses
• Stay current with validation trends, technologies, and regulatory updates

Skills

• Strong analytical and problem-solving abilities
• Knowledge of validation principles, quality systems, and regulatory requirements
• Proficiency in statistical analysis tools and validation software
• Excellent written and verbal communication skills
• Ability to work independently and manage multiple projects
• Familiarity with laboratory and manufacturing environments

Education/Experience

• Bachelor’s degree in Engineering, Life Sciences, or a related field required
• 5–7 years of experience in validation, quality assurance, or process engineering