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Validation Engineer
Job in
McPherson, McPherson County, Kansas, 67460, USA
Listed on 2026-07-08
Listing for:
FATHOM LIFE SCIENCES & TECHNOLOGY SERVICES
Full Time
position Listed on 2026-07-08
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
- Author and execute validation protocols for IQ, OQ, and PQ for the equipment as well as utilities, HVAC’s and facility.
- Ensure that the development and maintenance process are adequate in order, for the system to meet its objective.
- Responsible for document preparation and execution of validation protocols for a wide range of manufacturing equipment.
- Review validation deliverables to assure compliance with 21 CFR Part 11 (Electronic Signatures and Records) and FDA Regulations.
- Qualify the equipment based on cGMP (Good Manufacturing Practices) standards.
- Author and executed Qualification Protocols for HVAC’s, Freezers and controlled temperature units.
- Assist in development of Quality Control Systems in compliance with Part 820 of CFR Part 11.
- Qualify parts washer by following cGMP standards and using advanced quality control techniques.
- Review the Installation & Operational Qualification procedure of the newly installed Air Handling Unit (AHU) and generated the final qualification reports.
- Qualify parts washer by following cGMP standards and using advanced quality control techniques.
- Conduct thermal mapping studies using Data Loggers and Kaye Validator.
- Work along with the production team to increase the Quality standards of the product filling line and validation related activities.
- Author and Initiator of Events and Quality Assurance Reports in Global Quality tracking system using Track wise.
- Initiate Work orders and Action Items using EAMS
- Bachelor’s in Pharmacy or Equivalent is required
- 1-5 years relevant experience
- Strong technical writing to develop client SOPs
- Excellent attention to detail, analytical and problem-solving skills
- Experience in writing IQ, OQ and PQ protocols
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