Redbock - an NES Fircroft company
Equipment Qualification Specialist
Redbock - an NES Fircroft company, Salt Lake City, Utah, United States, 84193
Equipment Qualification Specialist
1 day ago Be among the first 25 applicants
A fast-growing biotechnology company is expanding their team in Salt Lake City, and they are in immediate need of an
Equipment Qualification Specialist
to support them fully onsite for
6 months .
The Quality Control (QC) team is seeking an equipment qualification and Empower integration specialist to support the onboarding, qualification, and performance verification of new analytical laboratory equipment in preparation for GMP commercial readiness. This role will lead to activities from Installation Qualification (IQ) through Performance Qualification (PQ) ensuring readiness for analytical testing in compliance with GMP standards and data integrity expectations. The ideal candidate will have hands‑on experience qualifying a variety of laboratory instruments ranging from simple devices to complex systems like HPLC/UPLC integrated with Empower Chromatography Data System. This specialist will also apply analytical experience to perform PQ testing according to analytical method SOP to ensure the equipment(s) is fully operational for QC release and stability programs.
Key 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
Required Qualifications
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 instrumentsHands‑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
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.
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A fast-growing biotechnology company is expanding their team in Salt Lake City, and they are in immediate need of an
Equipment Qualification Specialist
to support them fully onsite for
6 months .
The Quality Control (QC) team is seeking an equipment qualification and Empower integration specialist to support the onboarding, qualification, and performance verification of new analytical laboratory equipment in preparation for GMP commercial readiness. This role will lead to activities from Installation Qualification (IQ) through Performance Qualification (PQ) ensuring readiness for analytical testing in compliance with GMP standards and data integrity expectations. The ideal candidate will have hands‑on experience qualifying a variety of laboratory instruments ranging from simple devices to complex systems like HPLC/UPLC integrated with Empower Chromatography Data System. This specialist will also apply analytical experience to perform PQ testing according to analytical method SOP to ensure the equipment(s) is fully operational for QC release and stability programs.
Key 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
Required Qualifications
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 instrumentsHands‑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
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.
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