Senior Validation Engineer - Remote Biopharma GMP Leader

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

Job summary

Syner-G, a biopharma product development partner with offices across the U.S., is seeking a Sr. Validation Engineer in San Diego, CA.

With 7–11 years of experience, you will lead validation activities across equipment, utilities, facilities, and manufacturing processes in GMP environments, developing, executing, and managing lifecycle documentation. You will mentor junior staff, support tech transfer projects, audits, and regulatory responses, and ensure compliance with FDA cGMP and CSV

Qualifications

• Bachelor’s degree in life science, engineering, or related field.
• 7–11 years in biotech/pharma/medical device.
• Strong FDA cGMP knowledge and risk-based validation.
• Experience generating protocols for automated production systems.
• Experience supporting audits/regulatory inspections.

Responsibilities

• Lead validation lifecycle docs for equipment, utilities, facilities, and systems in GMP environments.
• Oversee validation activities for internal/client tech transfer projects and related docs.
• Write, review, and revise IQ/OQ/PQ and CSV reports and related docs.
• Prepare comprehensive summary reports for validation, verification, commissioning, and requalification.
• Mentor junior validation staff and support audits and regulatory responses.

Skills

Validation leadership

Regulatory knowledge

Documentation skills

Mentoring

Cross-functional collab

Education

Bachelor’s degree in life science/engineering

Tools

CSV validation

IQ/OQ/PQ protocols

Job description

Syner-G, a biopharma product development partner with offices across the U.S., is seeking a Sr. Validation Engineer in San Diego, CA.

With 7–11 years of experience, you will lead validation activities across equipment, utilities, facilities, and manufacturing processes in GMP environments, developing, executing, and managing lifecycle documentation. You will mentor junior staff, support tech transfer projects, audits, and regulatory responses, and ensure compliance with FDA cGMP and CSV