GxP Deployment Lead – Kneat Gx

GxP Deployment Lead – Kneat Gx
Location: Lawrenceville, NJ – Onsite
Experience: 10+ Years
Employment Type: W2 / C2C (as applicable)
Position Summary:
We are seeking an experienced GxP Deployment Lead with hands-on expertise in Kneat Gx to lead the implementation, configuration, validation, and rollout of paperless validation and digital execution processes within a regulated life sciences environment.The ideal candidate will act as a bridge between Business, Quality, IT, and Validation teams, ensuring successful, compliant, and inspection-ready deployments.

Key Responsibilities8–10+ years of experience working in GxP-regulated environments, preferably within pharmaceutical, biotech, medical device, or CDMO organizations.Hands-on experience with Kneat Gx is mandatory, including configuration, template design, workflow development, and deployment.Strong knowledge of CSV/CSA, GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity requirements.Proven experience leading software/system implementations and deployments in validated environments.Strong understanding of the validation lifecycle, including IQ/OQ/PQ, CQV, protocol execution, deviation management, and validation documentation.Experience with project planning, risk management, issue resolution, and stakeholder coordination.Ability to work effectively with Business, Quality, IT, QA, Validation, and other cross-functional teams. Excellent written and verbal communication skills, with strong presentation and stakeholder-management abilities. Ability to prepare and present project updates, deployment status, risks, issues, and recommendations to business and technical stakeholders.Bachelors degree in Life Sciences, Engineering, Computer Science, or a related field.Required SkillsMust Have:Kneat GxGxPCSV / CSAGAMP 521 CFR Part 11EU Annex 11Data IntegrityValidation / CQVSoftware/System DeploymentStakeholder ManagementStrong Communication amp; Presentation SkillsPreferred:Pharmaceutical / Biotech / Medical Device / CDMO experienceExperience with paperless validationExperience with digital execution platformsExperience working with QA and Quality Systems teams