Senior Validation Engineer

About Inventprise

At Inventprise, developing innovative and widely available vaccines is in our DNA. By producing targeted vaccines for populations worldwide, we're addressing global health inequalities and empowering people to live healthy lives—no matter where they live. Headquartered in Redmond, WA, 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. Inventprise is committed to creating a diverse and inclusive workplace, where our people are inspired to do their best work. We’re proud to have some of the world’s most qualified industry scientists, researchers, and manufacturing professionals on our team, and strive to create a vibrant, dynamic presence in the Washington State Life Sciences environment.

What the Role Offers - Senior Validation Engineer

The Senior Validation Engineer at Inventprise Inc. is responsible for ensuring adherence to quality system validation requirements; which concentrate on five areas of validation:

• Facilities / Utility / Equipment validation

• Process validation

• Cleaning validation

• Software validation

• Test method validation

 This includes authoring, executing and pre- / post-approving validation protocols (IQs / OQs / PQs) and associated reports in accordance with Inventprise procedures and regulatory  guidelines (e.g. FDA, WHO, PICS, etc.). Additionally, the incumbent  tracks progress against the Validation Master Plan, serves as an SME for validation training and reviews, investigates validation-related excursions, supports GMP drawings and change control, and   presents validation-related data and reporting to external parties and / or executive management, as required by Quality management. 

What You Need to Succeed

• Verification of / adherence to related Inventprise quality system validation requirements. This includes, but is not limited to, authoring, approving and executing validation protocols in accordance with Inventprise validation procedures, as well as FDA guidances for process validation, manufacturing equipment validation and the associated guidance for aseptic processing of sterile pharmaceutical product.
• Preparation of required IQ / OQ / PQ protocols and data reports, as needed.
• Tracking progress against / updating Validation Master Plan (VMP).
• SME for related validation training and validation reviews / project planning.
• Principle Investigator validation related excursions.
• Quality representative supporting related GMP drawings, drawing system and change control.
• Conducts internal validation protocols for selected items as assigned (e.g. temp mapping, etc.)

Required Qualifications:

• Bachelor's degree in the sciences and / or technical disciplines, preferably Engineering.

• Minimum 3 years of direct work experience (consistent with Essential Function responsibilities noted above) in the regulated (bio)pharmaceutical/biotech industry.

• Detailed familiarity with FDA and other applicable guidance documents and standards (e.g. ICH, ISO, ASQ. Etc.) on validation in the areas denoted in the Key Responsibilities section above. This also includes familiarity with the FDA guidance for aseptic processing.

• 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 exhibition of leadership qualities, as well as to take supervision to enact assigned projects.

Physical Demands:

• Must be present on site for all related responsibilities and be able to routinely perform activities as defined above.

• Must be able to stand for extended periods of time.

• Must be able to dress in sterile gowning in the form of scrubs and clean room coveralls.

• Ability to handle and work with potentially hazardous chemicals per standard operating procedure.

• Must be able to lift up to 30 pounds.

Mental Demands:

• Excellent oral and written communication skills.

• Highly organized with an attention to detail

• Must maintain a high level of alertness and acuity for analytical review and processing of documentation, daily.

• Able to work independently with changing priorities.

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.

Estimated Base Salary: $85,000 - $110,000 /yearly DOE

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. Medical plans are currently provided through Premera Blue Cross.

• 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.

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.
Our company was built on the belief that by working together, we have the ability to make the world a better place and improve lives. We have a growth mindset and are constantly looking for ways to enhance our contributions to improve global health. We believe that when we support each other and set high standards, we are able to do our best work.

Equal Opportunity Employer

Inventprise is an equal-opportunity employer. All qualified applications 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.