Computer System Validation – CSV Engineer

Job Title: CSV Engineer

Job Location: Raritan NJ (Onsite from day one)

Job Duration: 12 months

Minimum years of experience required: 7 years

Type of Hire: w2 contract

JOB DETAILS:

Request for Technology Quality Manufacturing and MES Services - 100% allocation / North America (Onshore).
Must have:
Strong CSV and Quality expertise with ability to independently lead validation activities across the SDLC for GxP systems with minimal supervision. 7-10 years of relevant experience.
Proven experience with Manufacturing MES and Data Platform Applications including support for global and regional GxP computerized systems.
Deep knowledge of GxP compliance FDA/Global regulations and Inspection Readiness.
Expertise in validation documentation and deliverables including review of compliance plans requirements design specs test protocols test scripts defects traceability reports and system procedures.
Demonstrated application of risk-based validation and risk management practices.
Effective leadership and mentoring skills guiding cross-functional and external teams (Senior and Junior consultants).
Strong project coordination and stakeholder communication skills including managing risks issues and status reporting.

Experience in writing documentation (i.e. Compliance Plan Test Plans Test Reports Compliance Summary Reports and SOPs).
Knowledge of Agile Tools (e.g. Jira Xray qTest etc.).
Ability to build collaborative partnerships work as a team player and support execution of business objectives across teams including timely escalations to TQ manager.
Primary Language required: English. Strong verbal and written communication skills.
Ability to work with dispersed/remote teams and support several projects simultaneously.
Experience with Acquisitions/Separations/Divestiture efforts from J&J is desirable. Please specify hourly rate when submitting resumes in response to this request.