---
title: 'Senior Quality, Compliance, and Regulatory Engineer at CAI'
canonical: 'https://feeny.ai/job/senior-quality-compliance-and-regulatory-engineer-cai-boston-wqpcnts79b74'
type: 'job'
last_seen: '2026-09-09'
---

# Senior Quality, Compliance, and Regulatory Engineer at CAI

- **Company:** CAI
- **Location:** Boston, MA
- **Compensation:** $130k–$175k
- **Employment:** full-time
- **Work type:** hybrid
- **Posted:** 2026-08-26
- **Last confirmed live:** 2026-09-09
- **Apply:** https://jobs.lever.co/cagents/7b29764c-d51f-40a5-99b7-09f6bb984c11

## Job description

Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field tested processes, and elite expertise developed over 30 years.

Our approach is simple because our Purpose informs everything we do:

- We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. At CAI, we are committed to living our Foundational Principles, both professionally and personally:
- We act with integrity
- We serve each other
- We serve society
- We work for our future At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done.

Job Summary: As the Senior Quality, Compliance, and Regulatory Engineer at CAI, you will serve as both a strategic leader and subject matter expert. You will be responsible for building, expanding, and leading the Practice Area function, ensuring excellence in service delivery and operational readiness and excellence. This role involves active participation in business development activities, including marketing, direct sales, and sales support across various regions. You will also play a key role in designing and implementing systems, processes, and initiatives that drive sustainable business growth.

Job Requirements:

1. Business Development & Industry Engagement: Work collaboratively with CAI agents to sell QCR services and deliver strategic project work Leverage your professional network to attract new business opportunities, generate leads, and secure assignments for consultants through proactive and targeted sales efforts Engage in industry forums, speaking, writing articles, participating in professional society committees, support standards or guidance document creation within such groups Build and maintain strong relationships with the regulatory authorities and other stakeholders as appropriate to ensure ease of access and influence.
2. Strategic & Expert Consulting Consult clients in Quality, Regulatory, and Compliance areas Fulfill Quality, Regulatory and Compliance roles, while managing client relationships for a portfolio of products and being responsible for close liaison with the management/ other key personnel in line with time frames per the project schedule. Engage in strategic project work designed to be a door-opener for larger teams once the initial expert engagement is over, or as part of a larger project to deliver specialized expertise.
3. Knowledge Leadership & Thought Contribution Create and contribute to content in industry-changing approaches that will benefit CAI web site and marketing materials. Provide significant support to PAL with respect to quality systems, knowledge management, services definition, and delivery in your area of expertise.
4. Talent Development Develop and grow agents through tailored professional development plans and initiatives

Qualifications: BS or higher in Biotechnology, Chemistry, Pharmaceutical Manufacturing Technology, Industrial Pharmaceutical Science, Pharmaceutical Technology and Quality Systems, Engineering, or a related, scientific discipline. 8+ years' experience in the life sciences industry with a proven track record of leading or collaborating effectively within cross-functional teams. In-depth knowledge of cGMP systems, Quality Assurance, regulatory affairs, pharmaceutical manufacturing, and testing, with direct experience in manufacturing environments. Prior experience in sterile manufacturing, biotechnology, medical device, and/or Cell and Gene is highly advantageous. Demonstrated technical leadership in the development and implementation of a Quality Management Systems (QMS)

Leadership Competencies: Leadership & Mentorship:

- Leads and mentors’ teams, influencing peers and stakeholders to achieve results. Communication Skills:
- Communicates clearly, writes technical documents, presents business ideas, and fosters collaboration. Decision-Making:
- Makes sound, timely decisions that benefit the team and broader organization. Gathers relevant information, asks insightful questions, and works with peers to identify optimal solutions Business Acumen:
- Delivers quality work, finds improvement opportunities, and simplifies processes. Drive:
- Shows initiative, self-management, and excellent organizational skills. Regulatory & Data Compliance Expertise:
- Knowledgeable in local and international data regulations, ensuring integrity, security, and compliance. Technical & cGMP Expertise:
- Skilled in cGMP environments, covering quality manufacturing, production practices, and systems. Learning Agility & Problem-Solving:
- Adaptable, resolves issues effectively, plans independently, and collaborates well. Positive Influence:
- Addresses problems, takes action, seeks feedback, and promotes continuous improvement. Influences outcomes positively. Relationship Building:
- Maintains strong relationships at all levels, shares knowledge, and communicates constructively.

## #LI-MV1

We are an equal opportunity employer; we are proud to employ veterans and promote a diverse culture 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 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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