Senior Validation Engineer

1 week ago

Woodinville, Washington, United States Inventprise LLC Full time
About Inventprise

Inventprise is a leading developer of innovative vaccines and technologies that have a global impact. Our mission is to address global health inequalities and empower people to live healthy lives, regardless of their location.

Job Summary

We are seeking a highly skilled Senior Validation Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring adherence to quality system validation requirements, including facilities, utility, equipment, process, cleaning, software, and test method validation.

Key Responsibilities
  • 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 a subject matter expert for validation training and reviews.
  • Investigate validation-related excursions, support GMP drawings and change control, and present validation-related data and reporting to external parties and/or executive 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.
  • 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.
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.
  • 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.
Our People-First Philosophy

At Inventprise, you'll be part of a world-class team working on innovative vaccines and technologies that have global impact. Our people are an integral part of our strategy, allowing us to grow as a company and improve our performance year-over-year.

We believe that when we support each other and set high standards, we are able to do our best work. Inventprise is an equal-opportunity employer and welcomes applications from diverse candidates.

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