Sr. Analyst IT Validation

Primary 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.

Education and Experience Requirements

BS / Equivalent Training / Certification and minimum of years of relevant experience in computer systems validation, change management and systems development life cycle methodologies.

Necessary Knowledge, Skills, and Abilities

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 specified quality and compliance goals. Solid relationship and conflict management skills, and ability to navigate complex, fast-moving, business environments in a self-directed manner.

Supervisory Responsibilities (if applicable) :

There are no supervisory responsibilities expected in this position.

• Summary of Work :

Job Title : Sr. Analyst, IT Validation Services

Department : Information Technology

Length of Assignment : Months Work Location : REMOTE Working days and Hours : Monday – Friday hours (AM-PM)