83 applicants
Inventprise · 1 week ago
Senior Validation Engineer
Woodinville, WA
Full-time
Onsite
Senior Level
$85K/yr - $105K/yr
3+ years exp
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Responsibilities
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.)
Qualification
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Required
Bachelor's degree in the sciences and / or technical disciplines, preferably Engineering.
Minimum 3 years of work experience (consistent with Essential Function responsibilities noted above) in the FDA-regulated industry, in pharmaceuticals or biotech.
Detailed familiarity with FDA guidance on process validation, equipment validation and the associated 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.
Ability to work in a team environment and take supervision to enact assigned projects.
Extended periods of time standing and walking in the user environment (e.g. manufacturing, laboratories).
Requires ability to don and maintain sterile gowning paraphernalia, without introducing potential for microbial contamination.
Extended periods of time on the computer.
Must maintain continuous levels of accurate mental acuity, while processing validation related data and documentation.
Benefits
Medical, Dental, Vision
FSA or HSA
401(k) program
Paid Time Off
Paid Holidays
Stock & Bonus Plans
Relocation package
Company
Inventprise
Inventprise is a biotechnology company specializing in GMP vaccine product development.
51-200 employees
H1B Sponsorship
Inventprise has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (4)
2022 (2)
2021 (4)
2020 (6)
Funding
Current Stage
Growth StageTotal Funding
$90MKey Investors
Bill & Melinda Gates Foundation
2021-11-10Grant· $90M
Leadership Team
Yves Leurquin
Chief Executive Officer
Jeff Wilson
Director Partnership & ERP
Company data provided by crunchbase
