Senior Validation Engineer - Lead GMP Validation, Remote

Initial Therapeutics, Inc.; California (MO); On-site; USD 115,000 - 130,000; Full time

Benefits offered by this job

Fully remote work options

Office locations in Greater Boston; Sa

Job summary

Syner-G 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 in GMP environments.

You will develop, execute, and manage validation lifecycle documentation while ensuring regulatory alignment and quality standards. You will mentor junior staff, support complex projects, and collaborate cross-functionally to keep validation efforts on track and aligned with client

Qualifications

• Bachelor’s degree in life sciences, engineering, or related field.
• 7–11 years in biotech/pharma/medical device.
• Strong knowledge of FDA cGMP, FMEA, and risk-based validation.
• Experience writing IQ, OQ, PQ and CSV reports.
• Ability to lead validation workstreams and mentor juniors.

Responsibilities

• Lead validation lifecycle documents (FAT, SAT, IOQ, PQ) for GMP assets.
• Oversee validation activities for internal and client tech transfer projects.
• Draft/review SOPs, validation master plans, URS/FS, design specs, and test protocols.
• Prepare summary reports for validation, verification, commissioning, and requalification.
• Mentor junior validation staff and guide cross-functional teams.
• Support regulatory audits and remediation activities.
• Lead P&ID walkdowns and thermal mapping tasks.
• Coordinate periodic requalification of validated assets.
• Ensure alignment with project timelines and client needs.

Skills

Communication

Organization

Leadership

Problem solving

Mentoring

Education

Bachelor’s degree (life sciences/engineering)

Tools

FAT/SAT/IOQ/PQ protocols

CSV validation

Job description

Syner-G 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 in GMP environments.

You will develop, execute, and manage validation lifecycle documentation while ensuring regulatory alignment and quality standards. You will mentor junior staff, support complex projects, and collaborate cross-functionally to keep validation efforts on track and aligned with client