---
title: 'Computer Systems Validation Engineer at CAI'
canonical: 'https://feeny.ai/job/computer-systems-validation-engineer-cai-boston-j8a4qbsg4zf4'
type: 'job'
last_seen: '2026-09-09'
---

# Computer Systems Validation Engineer at CAI

- **Company:** CAI
- **Location:** Boston, MA
- **Compensation:** $75k–$106k
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-08-26
- **Last confirmed live:** 2026-09-09
- **Apply:** https://jobs.lever.co/cagents/a4d67b13-9498-4956-ba1a-51718dce5082

## Job description

Are You Ready? CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries. Our approach is simple—we put the client’s interests first, we don’t stop until it’s right, and we do whatever it takes to get there.

Our Foundational Principles:

- We act with integrity
- We serve each other
- We serve society
- We work for our future

We work diligently to accomplish team goals and live our core values:

- Team Before Self
- Respect for Others
- Can-Do Attitude

This position could report to Rockville, MD or Frederick, MD

## Key Responsibilities

Documentation & Compliance Author GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test protocols and scripts Ensure adherence to 21 CFR Part 11 and data integrity principles Review and contribute to validation plans and risk assessments System & Industry Expertise Support CSV activities across various platforms including MES, DCS, SCADA, and batch systems Engage with major systems and platforms such as Rockwell PharmaSuite, Rockwell Automation platforms, Emerson DeltaV, DeltaV Batch, Emerson Syncade, PI, GE, ABB, Siemens, Honeywell, PAS-X, FactoryTalk, FactoryLogix, PLM, Simatic, iFix, Wonderware Apply knowledge of GAMP and compliance expectations (21 CFR Parts 210, 211, 11) Utilize familiarity with S88/S95 batch control standards Apply working knowledge of recipe authoring, batch recipe development, and S88-based recipe structures across systems such as DeltaV and Rockwell Client Support & Technical Execution Support client engagements with strong customer-service orientation Perform system assessments and remediation related to data integrity Collaborate with client teams to ensure validation compliance and delivery

## Qualifications and Experience

Bachelor’s degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted Minimum of 3+ years of experience in computer systems validation Experience in biotech or pharmaceutical environments preferred over medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211) Familiarity with S88/S95 batch control standards Experience with Rockwell platforms, DeltaV systems, and recipe authoring in batch environments strongly preferred Experience with multiple automation and manufacturing execution systems is highly desirable Data integrity assessment/remediation experience is a plus

Other Requirements

- Excellent oral and written communication skills in English
- Ability to travel domestically and internationally as required
- Willingness to work paid overtime when needed
- Must be authorized to work in the U.S. without current or future sponsorship

Critical Competencies Influence Strategy

- Pursues opportunities based on organizational fit and strategy
- Identifies high-impact, innovative solutions

Satisfy the Customer

- Anticipates and meets client needs
- Delivers high-quality solutions and maintains satisfaction

Plan for Success

- Aligns business goals with execution plans
- Allocates resources and builds risk mitigation strategies

Pursue Execution

- Prioritizes effectively and ensures accountability
- Proactively addresses challenges

Tailor Communication

- Communicates clearly and professionally
- Adapts style for technical and non-technical audiences

Build Partnerships

- Builds cross-functional networks
- Promotes collaboration and stakeholder engagement

Influence Others

- Gains support through sound reasoning
- Promotes innovation and value

Develop Self and Others

- Demonstrates integrity and commitment to growth
- Builds effective relationships internally and externally

## #LI-MV1

We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.

This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).

## About CAI

## Company Overview
- **One-liner**: CAI is a global professional services firm that accelerates operational readiness and excellence for life sciences and mission-critical facilities through commissioning, validation, engineering, and digital transformation expertise.
- **Entity Type**: Private (Privately Held; raised a venture round in May 2026)
- **Headquarters**: Indianapolis, Indiana, United States
- **Founded**: 1996
- **Founders**: Not publicly available

## Core Business
- **Primary industry/industries**: Life Sciences (pharmaceutical, biotech, medical device manufacturing) and Mission Critical (data centers, high-tech facilities)
- **Target customers**: B2B – enterprise-level pharmaceutical companies, biotech firms, data center operators, and regulated manufacturers
- **Mission or purpose statement**: “Making what’s next possible” by delivering precision, efficiency, and innovation through commissioning, qualification, validation, and operational readiness services.

## Products & Services
For each major offering:
- **Commissioning & Qualification (C&Q)**: End-to-end commissioning and qualification services for new and modified facilities, ensuring regulatory compliance and operational readiness.
- **Validation Services**: Computer Systems Validation (CSV), cleaning validation, process validation, and equipment validation for life sciences clients.
- **Automation & Digital Transformation**: Automation engineering, digital twin solutions, and technology integration to improve facility performance and data integrity.
- **Building Commissioning**: Mechanical, electrical, and plumbing commissioning for mission-critical buildings, including data centers and commercial facilities.
- **Human Performance & Operational Excellence**: Consulting and training programs to reduce human error, improve safety, and optimize asset management.
- **Project Management**: Owner’s project management and full-scale operations support for complex capital projects.

## Market Standing
- **Valuation/Market Cap**: Not disclosed (private)
- **Key Metric**: Annual Revenue of ~$10.2M (as of latest available data); Total Funding – venture round raised in May 2026 (amount undisclosed, 1 investor)
- **Notable Investors/Partners**: One venture investor (May 2026 round); strategic partnerships with technology vendors (unspecified) and participation in industry bodies such as ASHRAE, ASTM, BCA, and ISPE.
- **Growth Signals**: 
  - Employee headcount of 562, up 2.6% YoY
  - LinkedIn followers surged 72.3% over the past year, indicating strong brand interest
  - 84 active job postings globally
  - Offices in 5 countries (US, Ireland, Singapore, China, Australia) and operations across 21 countries
  - Clients include top pharma firms (Pfizer, Eli Lilly, MSD, Novartis, Thermo Fisher Scientific)

## Competitive Advantages
- **30 years of deep domain expertise** in highly regulated environments, giving CAI a track record that few competitors can match.
- **Elite, credentialed talent** – team members are active in nearly 30 professional societies and help set industry standards (ASHRAE, ISPE, ASTM, BCA).
- **Global footprint with local delivery** – ability to support multinational clients across the US, Europe, and Asia-Pacific.
- **End-to-end lifecycle support** – from commissioning and validation to digital transformation and operational excellence – reducing handoff risks.
- **Strong alumni pipeline to/from top pharma** – CAI attracts talent from Pfizer, Eli Lilly, Bristol Myers Squibb, and others, signaling deep industry credibility.

## Strategic Focus
- **Investing in Digital Transformation** – leveraging digital twin technology and automation to drive efficiency for clients.
- **Expanding Mission Critical Services** – actively hiring Data Center Commissioning Project Managers and Engineers in the US and Europe.
- **Sustainability Integration** – weaving green building practices (LEED, Net Zero Energy) into all client engagements.
- **Talent Development** – emphasizing top-tier training and career progression to retain high-knowledge employees.

## Why Work Here
- **Culture of teamwork and continuous improvement** – employee testimonials highlight a supportive team environment and commitment to process excellence.
- **Global, varied projects** – work on high-impact projects for leading pharma and data center clients across 21 countries.
- **Clear career growth** – career/professional development opportunities, exposure to multiple disciplines (validation, automation, commissioning, human performance).
- **Benefits package** – comprehensive health insurance, paid time off, competitive 401(k) contribution, income protection, and additional local-region benefits.
- **Remote/hybrid/office policy** – roles vary; many positions are client-site based (e.g., commissioning engineers travel to data centers or manufacturing sites). Some office locations available.
- **Engineering culture** – strong focus on quality, problem-solving, and precision; ideal for engineers, validation specialists, and project managers who thrive in regulated environments.

## Sources
1. [caiready.com](https://caiready.com/) – Company homepage and about page
2. [caiready.com/about](https://caiready.com/about/) – Company history and mission
3. [caiready.com/careers](https://caiready.com/careers/) – Careers page with benefits and culture
4. [linkedin.com/company/caiconnected](https://linkedin.com/company/caiconnected) – LinkedIn company profile and employee data
5. [jobs.lever.co/cagents](https://jobs.lever.co/cagents) – Active job postings

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