Cleaning Validation Specialist

Cleaning Validation Specialist

Our client, a leading biologics manufacturing company, is seeking an experienced Cleaning Validation Specialist to support cleaning validation activities for equipment upgrade projects within a cGMP manufacturing environment. This role will focus on developing and executing cleaning validation protocols for equipment such as centrifuges, CIP skids, transfer panels, and heat exchangers using Kneat Gx. The ideal candidate will have hands-on pharmaceutical or biotechnology cleaning validation experience, strong technical writing skills, and the ability to work collaboratively with cross-functional teams.

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.