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Validation Expert

2 months ago

Woodinville, Washington, United States Inventprise Full time
About Inventprise

Inventprise is a leading biotech 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 the Pacific Northwest and have a strong presence in the life sciences environment. Our team is comprised of world-class scientists, researchers, and manufacturing professionals who are passionate about creating a diverse and inclusive workplace.

Job Summary

We are seeking a highly skilled Senior Validation Engineer to join our team. The successful candidate will be responsible for ensuring adherence to quality system validation requirements, authoring and executing validation protocols, and tracking progress against the Validation Master Plan.

Key Responsibilities
  • Ensure adherence to quality system validation requirements, including facilities, utility, equipment, process, cleaning, software, and test method validation.
  • Author, execute, and pre-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 biopharmaceutical/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.
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.