RemoteLeaf Logo
Log in Sign up

Sr. Validation Engineer

3 weeks, 3 days 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 11

Description

  • Lead the 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, plans, IQ/OQ/PQ, test methods, and reports.
  • Write, review, and revise qualification, verification, and commissioning documents such as SOPs, URS, FRS, design specifications, and protocols.
  • Prepare summary reports for validation, verification, commissioning, and requalification activities.
  • Develop and support procedures, investigations, reports, and change controls for Maintenance, Engineering, and Quality functions.
  • Lead P&ID walkdowns to verify installation, configuration, and system readiness.
  • Perform and oversee thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.
  • Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation.
  • Provide technical mentorship and guidance to junior validation staff while collaborating cross-functionally on timelines and operational needs.

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 expertise in equipment, computerized systems (CSV), analytical methods, and process validation.
  • Extensive 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 validation workstreams, manage multiple priorities, work independently, and mentor junior engineers.
  • Experience with investigations and root-cause analysis is preferred.

Benefits

  • Market competitive base salary with annual incentive plan.
  • Expected salary range of $114,000 to $137,000 yearly.
  • Robust benefit offerings.
  • Generous flexible paid time off program.
  • Company-paid holidays.
  • Flexible working hours.
  • Fully remote work options for most positions.
  • Career development and ongoing recognition opportunities.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

kake

Senior QA Engineer

kake 1-10 Internet Software & Services

Senior QA Engineer responsible for ensuring software quality through scalable test automation, complex-system validation, and collaboration across the software development lifecycle in a remote environment.

United States Full-time Senior QA Engineer
AWS Azure C# CI/CD Cypress Docker Java JavaScript Jenkins Jest JMeter Kafka Kubernetes MongoDB Playwright TestNG TypeScript
6 hours, 2 minutes ago
NewRocket

ServiceNow Quality Analyst - ITSM

NewRocket 251-1K Internet Software & Services

NewRocket is hiring a ServiceNow Quality Analyst in India to plan, execute, and improve testing processes that ensure ServiceNow products are functional, reliable, user-friendly, and compliant with quality standards.

India Full-time Junior QA Engineer
6 hours, 32 minutes ago
Livefront

Quality Assurance Engineer [Zeal]

Livefront 11-50 Internet Software & Services

Zeal, now part of Livefront, is hiring a Quality Assurance Engineer in Peru to help clients deliver reliable software across web, mobile, API, and integrated systems.

Peru Mid Level QA Engineer SDET (Software Development Engineer in Test)
Appium Azure C# CI/CD Cypress Git GitHub Actions Java JavaScript Jenkins Playwright Postman Python REST API Selenium SQL TypeScript
2 days, 5 hours ago
DEFCON AI

QA Engineer - Clearance Required

DEFCON AI 11-50 Internet Software & Services

Defcon AI is hiring a remote QA Engineer to own quality for an AI-enabled decision-support system, defining and enforcing test coverage, release evidence, and acceptance verification across product, engineering, and platform teams.

United States Full-time Senior QA Engineer
$135k-$170k
CI/CD Cypress DevSecOps JavaScript JMeter K6 Locust Machine Learning Playwright Pytest Python Selenium TypeScript
2 days, 5 hours ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers