CSV Engineer
Raritan, New Jersey, United States of America
Contract
2 weeks ago
Key skills
JiraAgileSDLCLeadershipRisk ManagementMentoringCommunication
About this role
Job Details:
Role Overview:
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.
Role Overview:
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.