Kneat Validation Engineer

Job Title: Kneat Validation Engineer Location: North Carolina (Onsite)

Experience : 5 - 8 years Contract Type: Contract

Job Summary:

We’re looking for someone with solid validation experience and proven Kneat Gx Power User capabilities. You’ll support Engineering and Validation teams through equipment, system, and process qualification efforts. You must be comfortable building and managing Kneat Gx workspaces and user groups while staying compliant with GMP regulations. Strong writing, documentation, and troubleshooting skills are key.

Key Responsibilities:

Build and maintain Kneat Gx Workspaces and User Groups as a Power User

Perform commissioning and validation/qualification testing for equipment, utilities, and processes

Write risk assessments, protocols, and reports; manage execution and final documentation

Program and operate dataloggers for temperature/humidity chamber qualifications

Represent Technical Services in cross-functional teams for equipment and system implementation

Manage multiple deviation investigations and follow-up tasks to avoid delays in qualification timelines

Collaborate with process experts and production staff to understand and resolve technical issues

Recommend process improvements and provide expert support during troubleshooting

Use Word, Excel, Documentum, and other systems to complete documentation and reporting

Stay compliant with cGMPs, company policies, and safety regulations

Perform additional duties as assigned by management

Required Qualifications:

Bachelor’s degree in Engineering or Science (or equivalent experience)

Proven Kneat Gx Power User experience, including workspace and user group management

1–3 years’ experience in GMP-regulated manufacturing

Strong technical writing and documentation skills

Experience writing SOPs, protocols, and validation reports

Familiarity with FDA regulatory standards

Strong critical thinking, organization, and communication skills

Business minor is a plus