Associate Principal Validation Scientist

Trzdev35

Frederick, Maryland, US
Base: $138,338.40 - $207,507.60; bonus/equity: sho...
Not specified, but likely hybrid or onsite based on the nature of the role.
Computerized system validation (csv)
Gmp-regulated biopharmaceutical manufacturing
Process control systems (pcs)
Trzdev35 is seeking an Associate Principal Validation Scientist for its biopharmaceutical manufacturing facility in Frederick, Maryland. The role entails leading validation strategies and lifecycle execution for computerized manufacturing systems, emphasizing technical leadership in compliance and operational efficiency

Job Summary

  • This distinctive biologic manufacturing facility, with over 800 employees, makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe.
  • The Associate Principal Validation Scientist is a senior technical leader responsible for validation strategy, governance, and lifecycle execution for computerized manufacturing systems including Process Control Systems (PCS), automation platforms, historian infrastructure, and Manufacturing Execution Systems (MES) within a GMP-regulated biopharmaceutical manufacturing environment.
  • Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Matching Summary

Match Score: 85

Trzdev35 is seeking an Associate Principal Validation Scientist for its biopharmaceutical manufacturing facility in Frederick, Maryland. The role entails leading validation strategies and lifecycle execution for computerized manufacturing systems, emphasizing technical leadership in compliance and operational efficiency.

Salary

Base: $138,338.40 - $207,507.60; Bonus/Equity: short-term incentive bonus, equity-based long-term incentive program; Benefits: qualified retirement program, paid vacation and holidays, paid leaves, health benefits

Skills & Requirements

Must-have

  • computerized system validation (CSV)
  • GMP-regulated biopharmaceutical manufacturing
  • Process Control Systems (PCS)
  • Manufacturing Execution Systems (MES)
  • automation platforms
  • 21 CFR Part 11
  • Annex 11
  • GAMP 5 principles

Nice-to-have

  • continuous learning and skill building
  • inclusion and collaboration culture
  • risk-based validation approaches
  • data-driven decision-making
  • Lean/Six Sigma initiatives

Key Requirements

  • Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related technical field
  • 4+ years of experience in computerized system validation
  • Demonstrated ability to lead cross-functional validation efforts
  • Hands-on experience with automation platforms, PCS, historian systems, MES
  • Experience developing tools using Power BI, Power Apps, Power Automate, and Python

Work Rights

Not specified

Tailored Resume

Cover Letter