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← Genezen

Senior CSV Validation Engineer

Genezen
Location
Lexington, MA
Posted
18 days ago
Department
Operations
Salary
$115,000-$140,000
What they actually want (must-haves)
  • Bachelor’s degree in Engineering, Computer Science or related discipline
  • 7+ years of Computer System Validation experience
  • Strong understanding of GxP computerized systems and validation principles
  • Experience leading validation projects for Enterprise, Laboratory, Manufacturing, and Quality Systems
  • Demonstrated experience developing and executing risk-based CSV strategies
  • Experience with computerized system periodic reviews
What the job really is

The Senior CSV Validation Engineer at Genezen will lead computerized systems validation projects and support the data integrity program, ensuring compliance with regulatory requirements for GxP computerized systems and software applications. Responsibilities include preparing documentation, collaborating with cross-functional teams, and driving validation practices that support the company's Quality Management System. The role also involves evaluating data lifecycles, supporting audits, and promoting a strong data integrity culture across GxP functions.

Benefits
  • Paid vacation days, amount based on tenure
  • Paid sick time
  • 10 observed holidays + 2 floating holidays + 1 volunteer day
  • 401(k) plan with company match up to 6% of salary
  • Share Appreciation Rights
  • Choice of several healthcare plans
Things to weigh
  • No remote work mentioned, implying an on-site requirement in Lexington, MA
  • Criminal background check required for this position
  • No specific mention of career advancement opportunities or training programs
  • The role may involve adapting to changing work schedules based on business needs
Job score4.4/5
Benefits5/5
Freshness4/5
Career value4/5
Role clarity4/5
Pay transparency5/5

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