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Sr. Validation Engineer

2 months, 1 week ago
United States
Full-time
Senior
QA Engineer
Quality Assurance and Testing
Apply Now
Syner-G BioPharma

Syner-G BioPharma

Syner G BioPharma Group offers leading CMC & Regulatory Affairs solutions for biopharma, specializing in strategic CMC 360 services, global regulatory affairs, and quality compliance to support successful drug development.

Professional Services
51-250
Founded 2007
View All Jobs 8

Description

  • Lead generation and execution of validation lifecycle documentation for GMP-regulated assets.
  • Oversee validation activities for internal and client tech transfer projects.
  • Author, execute, review, and close validation documents including risk assessments, validation plans, IQ, OQ, PQ, test methods, and reports.
  • Write, review, and revise qualification, verification, SOP, and master plan documentation.
  • Prepare summary reports for validation, verification, commissioning, and requalification activities.
  • Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality.
  • Lead P&ID walkdowns to verify installation, configuration, and system readiness.
  • Perform and oversee thermal mapping for temperature-controlled chambers, warehouses, and SIP processes.
  • Support resolution of regulatory observations, audit findings, and manufacturing site validation issues.
  • Mentor junior validation staff and collaborate cross-functionally to meet project timelines.

Requirements

  • Bachelor’s degree in a life science, engineering, or related technical field.
  • 7–11 years of experience in the biotech, pharmaceutical, or medical device industry.
  • Strong knowledge of FDA cGMP requirements, FMEA, and risk-based validation principles.
  • Advanced validation experience in equipment, computerized systems (CSV), analytical methods, and process validation.
  • Experience generating protocols for automated production systems and computerized equipment validation.
  • Demonstrated experience writing and reviewing IQ, OQ, PQ, and CSV reports.
  • Experience supporting audits, regulatory inspections, and remediation activities.
  • Strong verbal and written communication skills.
  • Highly organized with strong documentation and analytical skills.
  • Ability to lead workstreams, manage multiple priorities, work independently, and mentor junior engineers.

Benefits

  • Market-competitive base salary with annual incentive plan.
  • Robust benefit offerings.
  • Generous flexible paid time off program.
  • Company-paid holidays.
  • Flexible working hours.
  • Fully remote work options for most positions, with ability to work almost anywhere.
  • Office locations available in Greater Boston, San Diego, Boulder, and India.

Interested in this position?

Apply directly on the company website

Apply Now

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