Sr. Analyst, IT Validation Services

Jobs via Dice; Stamford (CT); Remote; USD 80,000 - 115,000; Full time

Job summary

A growing pharmaceutical company is seeking a Sr. Analyst for IT Validation Services to ensure compliance with computer systems validation and oversight of various IT projects. This remote role requires strong expertise in validation methodologies, excellent communication skills, and collaboration across multiple teams to deliver compliant solutions effectively.

Qualifications

• Minimum of 5 years of relevant experience in computer systems validation.
• Expertise in CSV, SDLC methodologies, and relevant regulations.
• Excellent written and verbal communication skills.

Responsibilities

• Create, review, and process Computer System Lifecycle deliverables.
• Oversee test execution for cross-functional teams.
• Collaborate with ISQA for compliance on all projects.

Skills

Computer System Validation

Systems Development Life Cycle

Good Documentation Practices

Project Management Principles

Relationship Management

Education

BS/Equivalent Training/Certification

Tools

MS Office Suite

SAP

Veeva Vault

ServiceNow

LIMS

Job description

6 days ago Be among the first 25 applicants

Dice is the leading career destination for tech experts at every stage of their careers. Our client, Hired by Matrix, Inc., is seeking the following. Apply via Dice today!

At-a-Glance:

Are you ready to build your career by joining a pharmaceutical company? If so, our client is hiring a Sr. Analyst, IT Validation Services.

Position Type:

• Contact
• Remote
  
  

Required:

• BS/Equivalent Training/Certification and minimum of 5 years of relevant experience in computer systems validation, change management and systems development life cycle methodologies.
• Expertise in Computer System Validation (CSV), Systems Development Life Cycle (SDLC) methodologies and CSV regulations, standards, and best practices.
• Working knowledge of Computer Software Assurance (CSA) guidance and its applicability.
• Excellent written and verbal communication skills with a focus on Good Documentation Practices (GDP).
• Technical knowledge of the following computer systems and software (at a minimum):
• MS software packages such as Outlook, Word, Excel, PowerPoint and MS Project
• SAP, LIMS, or other Manufacturing, Distribution and Laboratory systems
• Veeva Vault
• ServiceNow
• Robust knowledge and understanding of pharmaceutical manufacturing, packaging, operations, quality, and supply chain processes and related systems.
• Working knowledge of project management principles, and ability to operate under tight timelines, within budget and to specify quality and compliance goals.
• Solid relationship and conflict management skills, and ability to navigate complex, fast-moving, business environments in a self-directed manner.
  
  

Responsibilities:

• Creation, review, approval, and DMS processing of Computer System Lifecycle deliverables for Projects and Change Controls:
• Validation Plans/Summary Reports
• Risk Assessments
• User Requirements
• Specifications
• Test Plans
• Test Scripts: IQ, OQ or PQ
• Assess and implement the most effective validation strategy for each activity.
• Oversee test execution for cross-functional teams, including training, tracking, and reviews. Build strong relationships with business counterparts to understand processes and requirements, ensuring delivery of compliant computer system solutions.
• Work effectively with IT colleagues to ensure compliance with validation processes and proper documentation.
• Collaborate with Information System Quality Assurance (ISQA) to ensure compliance on all projects, procedures and audits related to Information Technology.
  
  

Get in Touch:

If you think you'd be a good match, submit your resume and reach out to Prakash at to learn more.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Information Technology

• Industries

  Software Development

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