Cleaning Validation Specialist

Roles & Responsibilities

• Develop and author Cleaning Validation Protocols using Kneat Gx or similar electronic validation systems.
• Execute cleaning validation activities, including sampling, data collection, protocol execution, and documentation.
• Support validation of equipment upgrades, including centrifuges, CIP skids, transfer panels, and heat exchangers.
• Investigate validation issues, support troubleshooting activities, and perform protocol revisions or re-execution as required.
• Prepare and support cleaning validation reports, ensuring timely documentation and project closeout.
• Collaborate with cross-functional teams including SMEs, Quality Assurance (QA), Engineering, Manufacturing, and contractors.
• Ensure all validation activities comply with cGMP, company procedures, and regulatory requirements.
• Maintain accurate validation documentation and support audit readiness throughout project execution.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related discipline (or equivalent industry experience).
• Hands-on experience in Cleaning Validation within a cGMP pharmaceutical or biotechnology manufacturing environment.
• Experience authoring and executing cleaning validation protocols using Kneat Gx or similar electronic validation systems.
• Strong technical writing and documentation skills.
• Experience with cleaning validation of manufacturing equipment such as:
• CIP (Clean-In-Place) Systems
• SIP (Steam-In-Place) Systems
• Centrifuges
• Bioreactors
• Heat Exchangers
• Transfer Panels
• Strong understanding of cGMP documentation and validation lifecycle.
• Ability to work full-time onsite in the Twin Cities Metro during project execution.
• Experience supporting biologics or large molecule manufacturing facilities.
• Experience with equipment replacement, facility upgrades, or technology transfer projects.
• Familiarity with cross-functional project execution in regulated pharmaceutical manufacturing environments.

Pay

TBD

Schedule

Full-time onsite in the Twin Cities Metro during project execution.