Senior Engineer Computer Systems Validation

Bristol Myers Squibb

Confirmed live yesterday High trust

Quick summary

Work type
On-site
Location
Devens, MA
Salary
$99,480–$120,551 / yr
Posted
25 days ago
Freshness
Confirmed live yesterday
Closes
Oct 16, 2026

Market check

Salary context

Below market

How this pay compares to similar roles

Similar $176k
This role $110k
$86k most similar roles pay here $228k

This role pays less than 94% of similar roles. Most pay $144,650–$208,146 — the shaded band above. At the midpoint, this role pays about $110k versus about $176k for comparable roles.

Based on 240 similar postings.

Employer

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines to patients.

Bristol Myers Squibb currently has 33 open roles on FindRole.

Listed pay typically runs $125,480–$152,049 across 33 roles with salary data.

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At a glance

TL;DR · Senior Engineer Computer Systems Validation

Sr Engineer Computer Systems Validation serves as a subject matter expert for computerized system validation, IT compliance, and change management within a regulated manufacturing environment. Working with cross-functional teams including Quality, Manufacturing, and Engineering, this role manages lifecycle deliverables for systems at the Devens Campus and Cell Therapy Facility. Key responsibilities include executing CSV activities, managing deviations, performing root cause analysis, and overseeing risk management programs to ensure audit readiness. The candidate will develop GxP-related documentation and support data integrity initiatives. Required expertise includes knowledge of 21 CFR Part 11, 21 CFR Parts 210/211, GAMP, and ICH Q7, Q8, and Q9 standards. The role addresses the critical challenge of maintaining compliance for automated systems in cell and gene therapy or biologics manufacturing while ensuring high-quality data integrity across all digital assets and production processes.

What you'll do

  • Execute computer system validation (CSV) and IT compliance activities for regulated systems at the Devens Campus.
  • Serve as a subject matter expert for computerized system changes and associated IT/Automation projects.
  • Manage IT deviations, including root cause analysis, corrective actions, and preventive actions within the Quality Management System.
  • Provide guidance to site functional groups on CSV process implementation and address identified process deficiencies.
  • Support Data Integrity and Quality Risk Management programs for manufacturing environments.
  • Represent the Digital Plant during regulatory and internal audits while generating timely responses to observations.
  • Develop and maintain GxP-related procedures, guidance documents, and other compliance documentation.
  • Identify opportunities to improve CSV documentation efficiency and evaluate new technologies or process improvements.

What we're looking for

  • Bachelor's degree in Engineering, Science, Information Technology, or a related IT/OT discipline.
  • Minimum of 3–5 years of experience in Compliance and Computer System Validation (CSV).
  • Experience in Cell Therapy, Biologics Manufacturing, or related life sciences (preferred).
  • Solid knowledge of regulatory CSV requirements including FDA, EMA, and global standards like ICH Q7, Q8, and Q9.
  • Working knowledge of 21 CFR Part 11, 21 CFR Parts 210/211, GAMP, and Data Integrity.
  • Experience implementing quality systems, risk management, audit readiness, deviation management, and change management in automated manufacturing environments.
  • Strong project management, communication, and technical writing skills.
  • Experience in developing training materials and conducting training; experience with internal audits is an advantage (preferred).

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