Senior Validation Engineer: GMP Process & Tech Transfer

Syner-G BioPharma Group; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

Leading validation activities in a GMP regulated environment, the full-time Senior Validation Engineer will develop, execute, and manage validation lifecycle documentation while ensuring compliance with regulatory expectations and internal quality standards.

Key responsibilities include leading validation for FAT/SAT/IOQ/PQ, overseeing tech transfer validation documents, and mentoring junior staff while collaborating cross-functionally to align validation with timelines and quality requirements.

Qualifications

• Bachelor's degree in a life science, engineering, or related technical field.
• 7–11 years of experience in biotech, pharmaceutical, or medical device.
• Strong knowledge of FDA cGMP requirements and risk-based validation principles.
• Advanced validation expertise in equipment, computerized systems, and process validation.
• Experience supporting audits, regulatory inspections, and remediation activities.

Responsibilities

• Lead the generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ).
• Oversee validation activities for tech transfer projects, authoring and reviewing validation documents.
• Provide technical mentorship and guidance to junior validation staff while collaborating cross-functionally.

Skills

FDA cGMP knowledge

Risk-based validation

Equipment validation

Computerized systems validation

Process validation

Audits & regulatory inspections

Education

Bachelor's degree in life science, engineering or related field

Job description

Leading validation activities in a GMP regulated environment, the full-time Senior Validation Engineer will develop, execute, and manage validation lifecycle documentation while ensuring compliance with regulatory expectations and internal quality standards.

Key responsibilities include leading validation for FAT/SAT/IOQ/PQ, overseeing tech transfer validation documents, and mentoring junior staff while collaborating cross-functionally to align validation with timelines and quality requirements.