Senior Validation Engineer - Remote & Flexible Hours

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

Benefits offered by this job

Competitive compensation

Full benefits package

Remote-friendly policy where possible

Job summary

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

You will develop, execute, and manage validation documentation while ensuring regulatory and quality standards are met. You will mentor junior staff, support complex projects, and collaborate cross-functionally to align validation with project timelines and

Qualifications

• 7–11 years in biotech, pharmaceutical, or medical device industries.
• Strong knowledge of FDA cGMP requirements, FMEA, and risk-based validation principles.
• Experience generating IQ/OQ/PQ and CSV reports.

Responsibilities

• Lead generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, and GMP-regulated assets.
• Oversee validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents (risk assessments, validation plans, IQ/OQ/PQ, test methods, validation reports).
• Prepare comprehensive summary reports for validation, verification, commissioning, and requalification activities.
• Develop procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions.
• Mentor junior validation staff and lead cross-functional alignment with project timelines.

Skills

FDA cGMP

FMEA

Risk-based validation

IQ/OQ/PQ

CSV validation

Equipment validation

Education

Bachelor's degree in life sciences or related field

Job description

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

You will develop, execute, and manage validation documentation while ensuring regulatory and quality standards are met. You will mentor junior staff, support complex projects, and collaborate cross-functionally to align validation with project timelines and