Quality Assurance Validation Specialist

1 week ago

Woodinville, Washington, United States Inventprise Full time
About Inventprise

Inventprise is a leading biotechnology company dedicated to developing innovative vaccines and technologies that have a global impact. Our mission is to address global health inequalities and empower people to live healthy lives.

We are headquartered in Redmond, WA, and our goal is to deliver affordable, effective vaccines at large-scale to Low and Middle Income Countries, as well as populations in the U.S. and around the world.

Job Summary

We are seeking a highly skilled Senior Validation Engineer to join our Quality Assurance team. The successful candidate will be responsible for ensuring adherence to quality system validation requirements, authoring, executing and pre- / post-approving validation protocols, and associated reports in accordance with Inventprise procedures and regulatory guidelines.

Key Responsibilities
  • Ensure adherence to quality system validation requirements, including facilities / utility / equipment validation, process validation, cleaning validation, software validation, and test method validation.
  • Author, execute, and pre- / post-approve validation protocols (IQs / OQs / PQs) and associated reports in accordance with Inventprise procedures and regulatory guidelines.
  • Track progress against the Validation Master Plan and serve as an SME for validation training and reviews.
  • Investigate validation-related excursions and support GMP drawings and change control.
  • Present validation-related data and reporting to external parties and / or executive management, as required by Quality management.
Requirements
  • Bachelor's degree in the sciences and/or technical disciplines, preferably Engineering.
  • Minimum 3 years of direct work experience in the regulated (bio)pharmaceutical/biotech industry.
  • Detailed familiarity with FDA and other applicable guidance documents and standards on validation in the areas denoted in the Key Responsibilities section above.
  • Basic computer skills, Microsoft Word, Excel, etc.
  • Experience in authoring, approving, and executing validation protocols for major pharmaceutical manufacturing facilities, utilities, and equipment, with additional software validation experience preferred.
  • Proven written and verbal communication skills.
  • Must have analytical, problem-solving skills, and attention to detail.
  • Proven ability to work in a team environment, with an exhibition of leadership qualities, as well as to take supervision to enact assigned projects.
Working Conditions
  • Extended periods of time on the computer.
  • Extended periods of time on your feet.
  • Working in a warm environment wearing sterile gowning.
  • Working with chemicals per standard operating procedure.
Benefits
  • Medical, Dental, Vision, FSA, or HSA: Inventprise contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and their enrolled spouse, and dependents.
  • 401(k) program: Inventprise offers both pre-tax 401(k) and post-tax Roth retirement savings plans, letting you decide how you want to save for the future. We also make an employer contribution of 3% of your total earnings each pay period, regardless of whether you contribute.
  • Paid Time Off: Generous PTO, in addition to paid holidays.
  • Stock & Bonus Plans: Employees are eligible to participate in the Company's Bonus and Stock plans.

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