Full-Time
Quality Assurance Engineer
Batch Record and Change Control
CAI
1,001-5,000 employees
Operational readiness consulting for pharma
Compensation Overview
€34k - €45k/yr
Milan, Metropolitan City of Milan, Italy
Hybrid
Hybrid role; some on-site days in Milan.
 QA & Testing (1) |
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- 2–3 years of experience in a pharmaceutical GMP context
- Experience in production document management and/or Change Control
- Good knowledge of GMP regulations
- Excellent knowledge of the English language (written and spoken)
- Writing, reviewing and management of Master Batch Records
- Support the project to transition from paper Batch Records to Electronic Batch Records (eBR)
- Issuance, management and follow-up of Change Controls, coordinating with Production, QA, Engineering, Validation, and other functions
- Support for documentary compliance activities according to GMP
- Good relational and teamwork skills
CAI Technical Consulting Malaysia SDN (cagents.com) delivers operational readiness consulting for pharmaceutical, biotechnology, and healthcare clients to prepare for full-scale production. It works by conducting operational readiness assessments and then providing tailored implementation plans that cover project planning, production operations, asset management, reliability, and sustainability, plus specialized services like Digital Pathology Validation for Leica Biosystems. The firm differentiates itself through active industry collaboration, ongoing professional development, and a global, hands-on approach that pairs quick assessments with practical, cost-effective solutions. Its goal is to help clients achieve operational excellence and successful scale-up by delivering ready-to-deploy strategies and compliant processes.
Company Size
1,001-5,000
Company Stage
Pre-seed
Total Funding
$3.4M
Headquarters
Indianapolis, Indiana
Founded
1996
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See people who can refer or advise you
Simplify's Take
What believers are saying
- CAI closed JLL recapitalization on July 1, 2026, funding hiring, technology, and acquisitions.
- JLL's July 2026 news archive signals active platform-building across calibration and surface-science services.
- Australia expansion and new technology partnerships broaden CAI's customer base beyond North America.
What critics are saying
- CAI now faces JLL's growth targets; failed integration of tuck-ins will crush margins by 2027.
- Operational-readiness work depends on client capex; delayed FDA, data-center, and factory builds hit revenue fast.
- A failed recapitalization or acquisition spree turns CAI into a fragmented services roll-up by 2028.
What makes CAI unique
- CAI spans commissioning, qualification, validation, and operational readiness across regulated facilities.
- JLL Partners cited CAI's global footprint and 30-year reputation in mission-critical environments.
- Fedegari partnership links CAI directly to sterilization technology from procurement through operation.
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Benefits
100% Employee Owned
24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
Medical / Dental / Vision (In accordance with each countries’ applicable regulations)
Professional Development (Approximately $5,000 paid career-related, continuing education)
ESOP/401k – 15% Company Contribution
Company Paid Long-Term Disability
Company Paid Life Insurance
Company Paid Parental Leave (In accordance with each countries’ applicable regulations)
Other Benefits Depending on Country
Growth & Insights and Company News
6 month growth
↑ 4%1 year growth
↑ 4%2 year growth
↑ 4%/PRNewswire/ -- CAI, a professional services firm dedicated to accelerating operational readiness and excellence in life sciences and mission-critical...
CAI, a professional services firm specialising in operational readiness for life sciences and mission-critical environments, has agreed to a partnership with New York-based private equity firm JLL Partners to support its next growth phase. The investment will enable CAI to expand its global presence, invest in advanced technologies and enhance its service offerings. The company, which has operated for over 30 years, employs more than 700 professionals across North America, Europe, Australia and Asia. JLL Partners managing director Vikas Mouli cited CAI's reputation for launching cutting-edge facilities with precision and reliability. The transaction has signed definitive documentation but has not yet closed, pending regulatory approvals. CAI specialises in commissioning, qualification and validation services for highly regulated environments, helping organisations deploy complex facilities, systems and technologies.
INDIANAPOLIS--(BUSINESS WIRE)--CAI, a global company that provides technical, operational consulting, and project management services, today announced its strategic partnership with Fedegari Group, a manufacturer and service provider of high-performance sterilization systems. This partnership will elevate steam sterilization capabilities for companies spanning the life sciences and biotech industries. The goal of the partnership is to improve the application of steam sterilization science and minimize sterilization process implementation time, in order to reduce lifecycle costs, lower cost of goods, as well as streamline manufacturing processes. According to the terms of the partnership, Fedegari and CAI will integrate their offerings to provide a seamless experience from procurement to operation. In addition, the partners will cooperate on developing and validating state-of-the-art sterilization technology, driving science-based sterilization process and protecting both sensitive products and process equipment. "Fedegari is a world leader in providing aseptic manufacturing solutions, without operator intervention to produce advanced sterile products
Xtalks Life Science Webinars. . His wide-ranging expertise and experience will be integral to the discussion, particularly regarding the development and implementation of successful training programs
The ability to obtain medical commodities, raw materials, even transport and equipment is slowly beginning to normalize — that is to the ‘new’ normal, not at pre-pandemic levels. .