Senior Validation Engineer - GMP/CSV Lead (Remote)

Syner-G; San Diego (CA); On-site; USD 114,000 - 137,000; Full time

Benefits offered by this job

Flexible PTO

Company-paid holidays

Flexible working hours

Fully remote work options

Job summary

Syner-G is seeking a Sr. Validation Engineer to lead validation across equipment, utilities, facilities, computerized systems, and manufacturing processes in GMP-regulated environments. The role develops, executes, and manages validation lifecycle documentation, ensuring regulatory alignment and quality standards.

The Sr. Engineer will mentor juniors and guide complex projects. Key responsibilities include authoring and closing validation documents, conducting risk assessments, and supporting

Qualifications

• Bachelor’s degree in a life science, engineering, or related technical field.
• 7–11 years of experience in biotech, pharmaceutical, or medical device industry.
• Strong knowledge of FDA cGMP requirements, FMEA, and risk-based validation principles.
• Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and process validation.
• Experience writing and reviewing IQ, OQ, PQ, and CSV reports.
• Experience supporting audits, regulatory inspections, and remediation activities.

Responsibilities

• Lead generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for GMP-regulated assets.
• Oversee validation activities for internal and client tech transfer projects, including drafting, executing, reviewing, and closing validation documents.
• Write, review, and revise qualification and verification documents and SOPs, validation master plans, and design specifications.
• Prepare comprehensive summary reports for validation, verification, commissioning, and requalification.
• Lead P&ID walkdowns to verify installation and system readiness.
• Perform and oversee thermal mapping of temperature-controlled facilities and SIP processes.
• Support regulatory observations and manufacturing site issue resolution related to validation.

Skills

Verbal and written communication

Leadership

Documentation and analytics

Mentoring junior staff

Problem-solving

Education

Bachelor’s degree in life science or engineering

Tools

CSV (Computerized Systems)

IQ/OQ/PQ documentation

Job description

Syner-G is seeking a Sr. Validation Engineer to lead validation across equipment, utilities, facilities, computerized systems, and manufacturing processes in GMP-regulated environments. The role develops, executes, and manages validation lifecycle documentation, ensuring regulatory alignment and quality standards.

The Sr. Engineer will mentor juniors and guide complex projects. Key responsibilities include authoring and closing validation documents, conducting risk assessments, and supporting