Senior Validation Engineer — Remote, Flexible PTO

Initial Therapeutics, Inc.; California (MO); On-site; USD 114,000 - 137,000; Full time

Benefits offered by this job

Flexible PTO

Company-paid holidays

Flexible working hours

Fully remote work options

Ability to work almost anywhere

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 within GMP-regulated environments. The role develops, executes and manages validation lifecycle documentation, ensuring compliance with regulatory expectations and quality standards.

The Sr. Validation Engineer serves as a subject matter expert, supports complex projects, and mentors junior team members

Qualifications

• 7–11 years in biotech/pharmaceutical/medical device industries.
• Strong knowledge of FDA cGMP requirements and risk-based validation principles.
• Advanced validation expertise in equipment, computerized systems (CSV), analytics, and process validation.
• Experience generating and reviewing IQ/OQ/PQ and CSV reports.
• Experience supporting audits and regulatory inspections.

Responsibilities

• Lead generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for GMP-regulated assets.
• Oversee validation activities for internal and client tech transfers; author, execute, review, and close validation docs.
• Write, review, and revise qualification and verification documents (SOPs, validation master plans, URS, FRS, specs).
• Prepare comprehensive summary reports for validation, verification, commissioning and requalification activities.
• Develop procedures, investigations, protocols, and change controls for Maintenance, Engineering and Quality functions.
• Lead P&I D walkdowns to verify installation and system readiness.

Skills

Strong communication

Leadership

Mentorship

Analytical skills

Education

Bachelor’s degree in life sciences/engineering

Tools

IQ/OQ/PQ

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 within GMP-regulated environments. The role develops, executes and manages validation lifecycle documentation, ensuring compliance with regulatory expectations and quality standards.

The Sr. Validation Engineer serves as a subject matter expert, supports complex projects, and mentors junior team members