Validation Engineer

We’re ALTEN Technology USA, an engineering company helping clients bring groundbreaking ideas to life—from advancing space exploration and life‑saving medical devices to building autonomous electric vehicles. With 3,000+ experts across North America, we partner with leading companies in aerospace, medical devices, robotics, automotive, commercial vehicles, EVs, rail, and more.

As part of the global ALTEN Group—57,000+ engineers in 30 countries, we deliver across the entire product development cycle, from consulting to full project outsourcing.

When you join ALTEN Technology USA, you’ll collaborate on some of the world’s toughest engineering challenges, supported by mentorship, career growth opportunities, and comprehensive benefits. We take pride in fostering a culture where employees feel valued, supported, and inspired to grow.

The Validation Engineer II is responsible for planning, executing, and closing Installation and Operational Qualification (IOQ) activities for critical facility and utility systems within a pharmaceutical manufacturing environment. This includes system‑level qualification of clean rooms, utilities, and integrated manufacturing systems to ensure compliance with regulatory standards and internal quality requirements.

• System‑Level
  
  Qualification:
  
  Develop and execute IOQ protocols for facility and utility systems such as Water for Injection (WFI), clean steam, nitrogen/compressed air gases, and cleanroom environments.
• Protocol Development:
  Author detailed qualification protocols and ensure alignment with regulatory and company standards.
• Execution & Documentation:
  Perform qualification activities in cleanroom environments, document results, and manage deviations and corrective actions.
• Report Closure:
  Compile and finalize qualification reports, ensuring traceability and compliance with GMP and validation standards.
• Cross‑Functional
  
  Collaboration:
  
  Work closely with engineering, operations, and quality teams to maintain validated state of systems.
• Compliance & Standards:
  Ensure adherence to FDA, EMA, and ICH guidelines for system‑level validation.
• Continuous Improvement:
  Identify opportunities for improving qualification processes and system reliability.

• Education:
  
  Bachelor’s degree in Engineering, Life Sciences, or related field.
• Experience:
• 3–5 years of validation experience in pharmaceutical or biotech manufacturing.
• Hands‑on experience with system‑level qualification of critical utilities and cleanroom environments.
• Technical
  
  Skills:
• Strong understanding of GMP, FDA, and ICH guidelines.
• Proficiency in writing and executing IOQ protocols and reports.
• Other Requirements:
• Ability to work in cleanroom environments and adhere to gowning procedures.
• Excellent documentation and communication skills.
• Strong analytical and problem‑solving abilities.

• Experience with integrated manufacturing systems and risk‑based validation approaches.
• Familiarity with computerized systems validation and data integrity principles.

• $95,
• The actual salary offered is dependent on various factors including, but not limited to, location, the candidate’s combination of job‑related knowledge, qualifications, skills, education, training, and experience.

ALTEN Technology is an Equal Opportunity Employer. Our Policy is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual’s age, race, color, sex, religion, national origin, disability, sexual orientation, gender identity/expression or veteran status.

Please beware of job seeker scams and see this important notice on our careers page for more information about our recruiting process.

Compliance Notice: Alten USA is a federal contractor subject to the requirements of the Vietnam Era Veterans’ Readjustment Assistance Act (VEVRAA) and Executive Order 11246. We are an Equal Opportunity Employer and consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Drug Screening Requirement: As a federal contractor, Alten USA maintains a drug‑free workplace. All candidates selected for employment will be required to successfully complete a pre‑employment drug screening as a condition of hire.