Cleaning Validation Specialist

Position: Cleaning Validation Specialist

Location: Twin Cities Metro Area, MN

Duration: 12+ months

Work Arrangement: Hybrid during document development, transitioning to full-time onsite for the execution phase (must be based in or able to work onsite full-time in the Twin Cities Metro area)

About the Opportunity
We're seeking multiple Cleaning Validation Specialists to support documentation development and execution for an equipment replacement and process upgrade project at a large-scale biologics manufacturing facility. This role involves authoring and executing cleaning validation protocols within a modern, paperless electronic validation system, working alongside client subject matter experts, QA, and other technical resources.
This is a strong opportunity for a hands-on validation professional to gain exposure to large-scale biologics manufacturing equipment and electronic validation systems, with a defined project scope and clear timeline.

Key Responsibilities
Author cleaning validation protocols (new and modified cleaning pathways) within an electronic/paperless validation system
Execute cleaning validation protocols on-site, including sampling, data collection, and documentation
Support discrepancy investigation, punchlist resolution, and retesting as needed
Support cleaning validation report generation and closeout
Coordinate with client subject matter experts, QA, and other contract resources throughout document review and execution cycles

Required Qualifications
Prior hands-on experience authoring and/or executing cleaning validation protocols in a cGMP pharmaceutical/biotech manufacturing environment
Strong technical writing skills; comfortable with cGMP documentation practices and data integrity requirements
Must be based in, or willing/able to work onsite full-time in, the Twin Cities Metro area during the execution phase
Bachelor's degree in Engineering, Life Sciences, or a related field, or equivalent hands-on experience

Preferred Qualifications
Experience with CIP/SIP systems, centrifuges, bioreactors, or similar bioprocess equipment
Experience with Kneat Gx or comparable paperless/electronic validation systems
Large molecule/biologics facility experience
Experience supporting equipment replacement or tech transfer projects

Why This Role
Work on a defined, high-visibility equipment upgrade project at a large-scale biologics facility
Hands-on exposure to electronic/paperless validation systems and modern bioprocess equipment
Clear project phases and timeline, with strong potential for extension into future validation work
Multiple openings available on this engagement