Senior Quality Assurance Validation Engineer

Ready to shape the future of science and global health? ATCC, a leading nonprofit biological resources and standards organization, is seeking a Senior Quality Assurance Validation Engineer to work a hybrid schedule in Manassas, VA.We are seeking an experienced Quality Engineer with knowledge in equipment and process validation and biologics experience.

The Senior Quality Assurance Validation Engineer is responsible for planning, implementing, and ensuring compliance with manufacturing processes, focusing on adherence to internal and external safety, quality, and regulatory standards throughout the product lifecycle. This role involves validating life science product processes across the entire lifecycle, from research and development to manufacturing and distribution.

Join ATCC and be part of a team that supports the global scientific community with trusted, authenticated biological materials.

#LI-Hybrid

Quality Assurance Protocol Development and Maintenance: Develop, apply, revise, and maintain quality assurance protocols for validation activities.

Compliance Management and Analysis: Plan, implement, and manage compliance with safety, quality, and regulatory standards globally for biologics. Assure adherence to specifications and standards like GLP, GMP, ISO, and Six Sigma. Analyze production data, identify trends, and recommend updates to quality standards and procedures.

Validation and Auditing Activities: Conduct routine review and approval of manufacturing equipment testing. Collect, organize, and document test data, investigating and troubleshooting issues. Maintain accurate records of validation activities, review and approve validation protocols and perform and/or support internal and external audits.

Bachelor's degree and 5+ years' experience or equivalent.
• Demonstrated expertise in inspection, testing, and evaluation procedures specifically for equipment and processes used in biologics production.
• Analytical mindset with the ability to analyze production data, identify trends, and recommend updates to quality standards and procedures.
• Proven problem-solving skills with a strong track record in troubleshooting issues related to validation, compliance, and auditing activities.
  

The expected salary range for this position is $100,000 - $105,000 annually. Actual compensation will be determined based on experience and qualifications as well as internal equity and alignment with market data. In addition to base salary, this role may be eligible for additional incentive compensation including regular merit increases and the corporate bonus program.

We Invest in You

• Health & Wellness:
  • Comprehensive medical coverage and company paid Life Insurance, Disability Insurance & AD&D
  • Work life balance with Paid Holidays and PTO
  • Fitness and cell phone subsidies, and additional benefits such as Aflac, legal services, and pet insurance
  • Employee Assistance Program offering around-the-clock counseling
• Financial security:
  • 401(a) (6% employer contribution) and 403(b) (2% match) retirement plans
  • Exceptional career advancement opportunities, recognition, and rewards
  • Corporate bonus program
• Mission Focused:
  • Non-profit organization supporting critical life science research
  • We give scientists the tools they need to make discoveries that improve and save lives
  • Contribute to community involvement and social responsibility

Join ATCC, where we fuel your success, well-being, and development. We're a mission-focused non-profit Equal Opportunity Employer, celebrating a century of supporting global public health. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Shape the future of science with us.