CSV Engineer

Katalyst CRO; Raritan (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company in the pharmaceutical manufacturing sector is seeking a CSV Engineer. The role involves guiding project teams, applying FDA guidance, and managing SDLC deliverables. Candidates should have 3-7 years of experience in Computer System Validation and strong communication skills.

Qualifications

• 3-7 years' experience in Computer System Validation.
• Experience with FDA guidance and GxP applications.
• Proficient in project management tools.

Responsibilities

• Guide project teams on deliverables based on SDLC.
• Document and guide SDLC deliverables.
• Facilitate interaction between project teams and stakeholders.

Skills

Computer System Validation

Quality Management

Business Analysis

Project Management

Risk Assessment

Strong Communication Skills

Tools

ServiceNow

Automation Tools

JIRA

Job description

Join to apply for the CSV Engineer role at Katalyst CRO.

• 3-7 years' experience in Computer System Validation, Quality Management, or Business Analysis within the GxP application area.
• Experience with tool validation such as ServiceNow, Automation tools, JIRA.
• Guide project teams on applicable deliverables based on project type and SDLC.
• Apply FDA guidance and industry standards (e.g., GAMP), with a strong understanding of 21CFR Part 11 and Risk-Based Approach.
• Document and guide SDLC deliverables: Requirements Specification/User Stories, Criticality Assessment, Test Plan, Validation Plan, Risk Assessment, Validation Strategy, Test Summary, Requirement Trace Matrix.
• Strong communication skills for interaction with stakeholders like Technology Leaders, Project Managers, Business Owners.
• Facilitate interaction between project teams and business stakeholders.
• Manage and train teams on policies, SDLC processes, procedures, and tools.
• Proficient in Project Management tools like JIRA.
• Prioritize projects based on risk assessment.

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Pharmaceutical Manufacturing