Senior Validation Engineer — Lead GMP Validation, Remote

Syner G; San Diego (CA); Remote; USD 115,000 - 145,000; Full time

Benefits offered by this job

Remote work options

Office locations in San Diego and US

Competitive compensation

Job summary

Syner-G is seeking a Sr. Validation Engineer in San Diego, CA, with 7–11 years’ experience to lead validation activities across equipment, utilities, facilities, and manufacturing processes in GMP-regulated environments.

You will develop, execute and manage lifecycle documentation, provide guidance to junior staff, and ensure regulatory alignment. The role requires strong CQ knowledge, ability to mentor, and collaboration across functions to meet project needs and timelines.

Qualifications

• Bachelor’s degree in life science, engineering, or a related field.
• 7–11 years of biotech/pharma/medical device experience.
• Strong knowledge of FDA cGMP, FMEA, and risk-based validation.
• Experience writing and reviewing IQ/OQ/PQ/CSV reports.
• Experience supporting audits and regulatory inspections.

Responsibilities

• Lead generation and execution of validation lifecycle documents (FAT, SAT, IOQ, PQ).
• Oversee validation activities for tech transfer projects and validation reports.
• Write, review, and revise qualification documents and validation plans.
• Prepare comprehensive summary reports for validation and commissioning.
• Mentor junior validation staff; collaborate cross-functionally to meet timelines.
• Lead P&ID walkdowns and thermal mapping activities.

Skills

Strong communication

Leadership

Documentation

Regulatory knowledge

Education

Bachelor’s degree in life science or engineering

Tools

CSV validation

IQ/OQ/PQ experience

Job description

Syner-G is seeking a Sr. Validation Engineer in San Diego, CA, with 7–11 years’ experience to lead validation activities across equipment, utilities, facilities, and manufacturing processes in GMP-regulated environments.

You will develop, execute and manage lifecycle documentation, provide guidance to junior staff, and ensure regulatory alignment. The role requires strong CQ knowledge, ability to mentor, and collaboration across functions to meet project needs and timelines.