Kneat Digital Validation Specialist (CSV & GxP)

United Pharma; Pennsylvania; Vor Ort; USD 120.000 - 190.000; Vollzeit

Zusammenfassung

United Pharma seeks an experienced Kneat Subject Matter Expert to support a major digital validation initiative at a Pennsylvania biopharmaceutical facility. You will be the primary Kneat expert, partnering with Quality, Validation, Engineering, Manufacturing, and IT to drive adoption, standardize processes, migrate qualification content, and establish best practices for long-term success.

The role requires hands-on Kneat administration, strong GxP knowledge, and the ability to lead deployment

Qualifikationen

• Bachelor's degree in Engineering, Life Sciences, Computer Science, or related discipline.
• 5+ years of CSV/CQV/Validation or Quality Systems experience in pharma/biotech/medical device.
• Hands-on Kneat experience as administrator, author, reviewer, or implementation lead.
• Experience supporting paperless validation initiatives in regulated GxP environments.
• Strong understanding of GAMP 5, ASTM E2500, 21 CFR Part 11, Data Integrity principles, SDLC.
• Experience developing and executing validation protocols and risk assessments.
• Outstanding communication and stakeholder management skills.
• Ability to lead discussions, influence decisions, and drive project deliverables.

Aufgaben

• Act as the site Kneat SME and lead paperless validation initiatives.
• Lead Kneat implementations, enhancements, and expansion efforts.
• Develop deployment strategies, governance models, and adoption plans.
• Facilitate workshops with stakeholders to define requirements.
• Drive continuous improvement of digital validation processes.

Kenntnisse

Kneat platform

GxP compliance

Stakeholder management

Project leadership

Data integrity

SDLC

Regulatory knowledge

Ausbildung

Bachelor's degree in Engineering, Life Sciences, Computer Science, or related

Tools

ValGenesis

Veeva

MasterControl

TrackWise

Jobbeschreibung

United Pharma seeks an experienced Kneat Subject Matter Expert to support a major digital validation initiative at a Pennsylvania biopharmaceutical facility. You will be the primary Kneat expert, partnering with Quality, Validation, Engineering, Manufacturing, and IT to drive adoption, standardize processes, migrate qualification content, and establish best practices for long-term success.

The role requires hands-on Kneat administration, strong GxP knowledge, and the ability to lead deployment