Senior Validation Engineer - Remote Life Sciences

Syner-G BioPharma Group; San Diego (CA); On-site; USD 110,000 - 125,000; Full time

Job summary

Syner-G BioPharma Group is seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP-regulated environments.

You will develop, execute, and manage validation lifecycle documentation, ensuring compliance with regulatory expectations and internal quality standards. The role includes mentorship of junior staff and collaboration across functions to align with

Qualifications

• Bachelor’s degree in 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 IQ, OQ, PQ, and CSV reports.
• Experience supporting audits, regulatory inspections, and remediation activities.

Responsibilities

• Lead validation lifecycle documentation (FAT, SAT, IOQ, PQ) for GMP assets.
• Oversee validation activities for internal and client tech transfer projects and related documents.
• Write, review, and revise qualification and verification documents (SOPs, validation master plans, URS, FRS).
• Prepare comprehensive summary reports for validation, verification, commissioning, and requalification activities.
• Lead P&ID walkdowns to verify installation and readiness.
• Perform and oversee thermal mapping of temperature-controlled chambers and SIP processes.
• Mentor junior validation staff and coordinate cross-functional teams.

Skills

Communication

Leadership

Mentorship

Documentation

Analytical skills

Education

Bachelor's degree

Job description

Syner-G BioPharma Group is seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP-regulated environments.

You will develop, execute, and manage validation lifecycle documentation, ensuring compliance with regulatory expectations and internal quality standards. The role includes mentorship of junior staff and collaboration across functions to align with