Lead Quality Assurance Engineer

1 week ago

Woodinville, Washington, United States Inventprise Full time

About Inventprise

At Inventprise, our mission is to create groundbreaking and accessible vaccines. We focus on developing targeted immunizations for diverse populations globally, tackling health disparities and enabling individuals to lead healthier lives, regardless of their location. Our headquarters in Redmond, WA, is dedicated to delivering cost-effective and efficient vaccines at scale to Low and Middle Income Countries, as well as communities in the U.S. and beyond. We are committed to fostering a diverse and inclusive workplace, inspiring our team to excel. Our workforce includes some of the most skilled scientists, researchers, and manufacturing experts in the industry, contributing to a vibrant and dynamic presence in the Washington State Life Sciences sector.

Role Overview - Lead Quality Assurance Engineer

The Lead Quality Assurance Engineer at Inventprise Inc. plays a crucial role in ensuring compliance with quality system validation standards, focusing on five key areas:

  • Facility / Utility / Equipment Validation
  • Process validation
  • Cleaning validation
  • Software validation
  • Test method validation

This position involves drafting, executing, and reviewing validation protocols (IQs / OQs / PQs) and related reports in line with Inventprise procedures and regulatory standards (e.g., FDA, WHO, PICS, etc.). The individual will monitor progress against the Validation Master Plan, act as a Subject Matter Expert (SME) for validation training and assessments, investigate validation-related issues, support Good Manufacturing Practice (GMP) documentation and change control, and present validation data and reports to external stakeholders and/or senior management as required by Quality management.

Qualifications for Success

  • Verification of compliance with Inventprise quality system validation standards, including drafting, approving, and executing validation protocols in accordance with Inventprise validation procedures and FDA guidelines for process validation, manufacturing equipment validation, and aseptic processing of sterile pharmaceutical products.
  • Preparation of necessary IQ / OQ / PQ protocols and data reports as required.
  • Monitoring progress against and updating the Validation Master Plan (VMP).
  • Acting as an SME for validation training and project planning.
  • Leading investigations into validation-related issues.
  • Serving as a quality representative for GMP documentation and change control.
  • Conducting internal validation protocols for selected items as assigned (e.g., temperature mapping, etc.).

Essential Qualifications:

  • Bachelor's degree in a scientific or technical field, preferably Engineering.
  • A minimum of 3 years of relevant experience in the regulated (bio)pharmaceutical/biotech sector.
  • In-depth knowledge of FDA and other relevant guidance documents and standards (e.g., ICH, ISO, ASQ, etc.) related to validation in the areas outlined in the Key Responsibilities section.
  • Basic proficiency in computer applications, including Microsoft Word and Excel.
  • Experience in drafting, approving, and executing validation protocols for major pharmaceutical manufacturing facilities, utilities, and equipment, with additional software validation experience preferred.
  • Strong written and verbal communication skills.
  • Demonstrated analytical and problem-solving abilities, with a keen attention to detail.
  • Proven ability to collaborate effectively in a team environment, demonstrating leadership qualities and the capacity to work independently on assigned projects.

Physical Requirements:

  • Presence on-site for all related responsibilities, with the ability to perform activities as outlined.
  • Capability to stand for extended periods.
  • Ability to wear sterile gowning, including scrubs and clean room coveralls.
  • Proficiency in handling and working with potentially hazardous chemicals according to standard operating procedures.
  • Ability to lift up to 30 pounds.

Mental Requirements:

  • Excellent oral and written communication skills.
  • Highly organized with a strong attention to detail.
  • Ability to maintain a high level of alertness and focus for analytical review and documentation processing on a daily basis.
  • Able to work independently while managing changing priorities.

Work Environment:

  • Extended periods of time spent on the computer.
  • Extended periods of time spent on your feet.
  • Working in a warm environment while wearing sterile gowning.
  • Handling chemicals in accordance with standard operating procedures.

Compensation and Benefits:

  • Estimated Base Salary: $85,000 - $110,000 annually, depending on experience.
  • Comprehensive Medical, Dental, and Vision coverage, with Inventprise contributing 80% toward the costs for employees and their enrolled dependents.
  • 401(k) program with both pre-tax and post-tax Roth retirement savings options, including a 3% employer contribution of total earnings each pay period.
  • Generous Paid Time Off, in addition to paid holidays.
  • Eligibility for the Company's Bonus and Stock plans.

Our People-First Philosophy

At Inventprise, you will join a world-class team dedicated to developing innovative vaccines and technologies that have a significant global impact. Our people are central to our strategy, enabling us to grow and enhance our performance year after year.

Our organization is founded on the belief that collaboration empowers us to improve the world and enhance lives. We maintain a growth mindset, continuously seeking ways to enhance our contributions to global health. By supporting one another and setting high standards, we can achieve our best work.

Equal Opportunity Employer

Inventprise is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, age, gender, identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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