Title: Cleaning Validation Specialist
Location: St Paul, MN
Summary:
Support cleaning validation for equipment upgrades (centrifuge, CIP skid, transfer panel, heat exchanger) at a large biologics manufacturing site. Write and execute cleaning validation protocols using Kneat Gx.
What you'll do:
- Write cleaning validation protocols in Kneat Gx
- Execute protocols on-site (sampling, data collection, documentation)
- Help resolve issues and retest as needed
- Support report writing and closeout
- Coordinate with client teams (SMEs, QA, contractors)
Must have:
- Hands-on cleaning validation experience in cGMP pharma/biotech
- Experience with Kneat Gx or similar electronic validation systems
- Strong technical writing skills, comfortable with cGMP documentation
- Bachelor's degree in engineering, life sciences, or related field (or equivalent experience)
- Must be on-site full-time in Twin Cities Metro during execution
- Experience with CIP/SIP systems, centrifuges, bioreactors, or similar equipment
Nice to have:
- Biologics/large molecule facility experience
- Experience with equipment replacement or tech transfer projects
Pay: $40.00 - $65.00 per hour
Work Location: In person
