Redbock - an NES Fircroft company · 22 hours ago
Equipment Qualification Specialist
SLC Metro Area
Contract
Onsite
Senior Level
$30/hr - $40/hr
5+ years expRedbock, an NES Fircroft company, is a fast-growing biotechnology company expanding their team in Salt Lake City. They are seeking an Equipment Qualification Specialist to support the onboarding, qualification, and performance verification of new analytical laboratory equipment in preparation for GMP commercial readiness.
BiotechnologyConsultingMedical DevicePharmaceutical
Hiring Manager
Julia Kupin
Responsibilities
Plan, coordinate, and execute equipment qualification activities (IQ,OQ,PQ) for new and existing QC instruments
Work cross-functionally with Validation, IT and QA to ensure timely completion of qualification deliverables and data integrity compliance
Draft, review, and execute qualification protocols, test scripts, and PQ reports in accordance with GMP and company procedures
Perform PQ testing independently and/or in collaboration with QC-Chemist SME using analytical methods and the associated instruments SOP to confirm equipment performance
Partner with vendors and internal teams for equipment installation, calibration, and documentation review
Ensure qualification documents meets regulatory and audit-ready standards
Support Empower Chromatography System setup and integration activities for applicable instruments (bonus skill)
Contribute to laboratory readiness for method validation, release and stability testing
Maintain equipment lifecycle documentation, calibration schedules and change controls
Support deviation investigations, CAPA, and continuous improvement activities related to laboratory equipment and qualification
Qualification
Required
Bachelor's degree in chemistry, Biochemistry, or a related field
5 + years' experience in a GMP QC and Analytical Development environment
Proven experience in equipment qualification and validation across a range of analytical instruments
Hands-on analytical laboratory experience, able to execute PQ testing per analytical SOPs
Familiarity with data integrity, computer system validation and 21CFR Part 11 compliance
Demonstrated ability to manage multiple priorities and meet project timelines
Excellent interpersonal communication skills, able to work collaboratively with cross-functional partners
Preferred
Experience supporting GMP testing and equipment qualification in a biologics QC lab is strongly preferred
Working knowledge of Empower Chromatography System (CDS) or other CDS platforms (e.g. OpenLAB, 32 Karat) is a plus
Experience qualifying both simple and complex QC instruments
Previous experience supporting GMP commercial readiness or new laboratory startup activities
Company
Redbock - an NES Fircroft company
Redbock is a consultancy that delivers customized resourcing solutions to pharmaceutical, biotechnology, medical device and diagnostics companies.
51-200 employees
H1B Sponsorship
Redbock - an NES Fircroft company 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (5)
2023 (1)
2022 (1)
2021 (8)
2020 (9)
Funding
Current Stage
Growth StageTotal Funding
unknown2018-06-20Acquired
Company data provided by crunchbase