Equipment Qualification Specialist; Onsite :Salt Lake , Utah

Equipment Qualification Specialist(Onsite)

Location:
Salt Lake City, Utah

Interview:

Phone+Skype

Job Description:

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.

• 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

• 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 21
  
  CFR 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

• 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.