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Senior Validation Engineer

2 weeks, 6 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 8

Description

  • Lead and execute validation lifecycle documentation, including FAT, SAT, IOQ, IQ, OQ, and PQ activities.
  • Manage validation for internal and client technology-transfer projects, from risk assessments and protocols through execution and final reports.
  • Author, review, and revise SOPs, validation master plans, URS, design specifications, commissioning procedures, and verification documents.
  • Prepare summary reports for validation, verification, commissioning, and requalification activities.
  • Develop procedures, investigations, protocols, reports, and change controls for Engineering, Maintenance, and Quality functions.
  • Lead P&ID walkdowns and thermal mapping for temperature-controlled chambers, warehouses, and SIP processes.
  • Support regulatory observations, audit findings, inspections, remediation activities, and manufacturing site issues.
  • Lead periodic reviews and requalification of temperature-controlled systems and other validated assets.
  • Mentor junior validation staff and collaborate cross-functionally to align work with project timelines and operational needs.

Requirements

  • Bachelor’s degree in life science, engineering, or a related technical field.
  • 7–11 years of experience in the biotechnology, pharmaceutical, or medical device industry.
  • Strong knowledge of FDA cGMP requirements, FMEA, and risk-based validation principles.
  • Advanced experience with equipment validation, computerized systems validation, analytical methods, and process validation.
  • Experience developing protocols for automated production systems and computerized equipment.
  • Demonstrated experience writing and reviewing IQ, OQ, PQ, and CSV reports.
  • Experience supporting audits, regulatory inspections, investigations, root-cause analysis, and remediation activities.
  • Strong written, verbal, organizational, documentation, analytical, and problem-solving skills.
  • Ability to lead workstreams, manage multiple priorities independently, explain technical concepts, and mentor junior engineers.
  • Ability to lift and carry objects weighing up to 25 pounds; visa sponsorship is not available.

Benefits

  • Annual salary range of $115,000–$130,000.
  • Annual incentive plan and competitive benefits package.
  • Flexible paid time off and company-paid holidays.
  • Flexible working hours and fully remote work options for most positions.
  • Ability to work from many locations, with offices in Greater Boston, San Diego, Boulder, and India.
  • Career development, learning, recognition, and growth opportunities.

Interested in this position?

Apply directly on the company website

Apply Now

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