Overview
On Site
Full Time
Skills
Manufacturing Operations
Pharmaceutics
Manufacturing
Adobe AIR
Reporting
Siemens
IQ
OQ
PQ
Legacy Systems
GMP
Management
Documentation
Document Management
Regulatory Compliance
Collaboration
Job Details
Job Description:
- A pharmaceutical/biotech client in Utah is seeking a mid-to-senior level Utilities Qualification Engineer with 5+ years of experience in critical utilities validation and qualification.
- The candidate will support GMP manufacturing operations by qualifying and documenting systems like AHUs, purified water, compressed air, and legacy cleanroom systems.
- This is a fully onsite role and requires a self-driven individual with hands-on experience in IQ/OQ/PQ, EDMS tools (Glorya preferred), and GMP environments.
- 5+ years of experience in utilities qualification in GMP pharma/biotech manufacturing.
- Expert in IQ/OQ/PQ for utility system.
- Air Handling Units (AHUs).
- Clean Compressed Dry Air System.
- Purified Water Systems.
- Legacy system qualification and annual report generation.
- Siemens Desigo, Apogee, AHU PLCs, EDMS platform.
- Execute and document utility qualification protocols (IQ/OQ/PQ).
- Review and compile annual reports for legacy systems.
- Support validation initiatives in production-focused GMP settings.
- Draft and manage validation documentation using MS Word and EDMS.
- Summarize large system datasets into regulatory-compliant formats.
- Ensure compliance through collaboration with internal quality and IT stakeholders.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.