CAI
Operational readiness consulting for pharma
Automation Engineer - Manufacturing Support
Site-based role with a minimum 40-hour work week.
About the job
- A bachelor's degree in Automation, Electrical, Electronic, or Computer Engineering, or a related discipline.
- At least 3 years of experience in automation engineering within a pharmaceutical, biotechnology, or regulated manufacturing environment.
- Experience supporting manufacturing automation systems and laboratory or quality control equipment.
- Experience managing or supporting change control processes in a good manufacturing practice environment.
- Strong troubleshooting and problem-solving skills.
- The ability to commit to a minimum 40-hour work week, with flexibility based on project needs.
- Provide day-to-day automation support for manufacturing and laboratory systems.
- Troubleshoot automation issues impacting manufacturing processes and quality control laboratory equipment.
- Support the qualification and automation readiness of laboratory and quality control equipment.
- Act as the automation subject matter expert for new equipment introduction, supporting system testing, setup, and commissioning.
- Support automation change control activities across manufacturing and laboratory systems.
- Investigate automation-related deviations and support corrective and preventive action implementation.
- Collaborate with Manufacturing, Quality Control, Engineering, Validation, Quality Assurance, and Information Technology teams to ensure systems remain compliant and operational.
- Support commissioning, qualification, and startup activities for new equipment and automation systems.
- Ensure automation systems operate in compliance with good manufacturing practice and data integrity requirements.
- Experience supporting biopharmaceutical manufacturing equipment.
- Experience with equipment qualification and validation activities.
- Understanding of good manufacturing practice, Good Automated Manufacturing Practice 5, and data integrity requirements.
About the company
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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Simplify's Take
What believers are saying
- JLL closed July 1, 2026, funding talent, technology, and acquisitions.
- CAI hired a Senior Applied AI Architect on August 3, 2026.
- Australia expansion and Fedegari integration widen CAI’s addressable regulated-market revenue.
What critics are saying
- JLL’s July 1, 2026 recapitalization raises pressure for acquisitions and rapid growth.
- AWS, Microsoft, and Anthropic partnerships commoditize advisory work within 12 months.
- CAI’s expert-heavy model breaks if senior engineers leave during 2026 expansion.
What makes CAI unique
- CAI bundles CQV, commissioning, and validation for regulated life sciences plants.
- Its 700-plus specialists operate across North America, Europe, Australia, and Asia.
- The Fedegari partnership links procurement through operation, speeding sterilization launches.
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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
↑ 3%1 year growth
↑ 3%2 year growth
↑ 3%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.
/PRNewswire/ -- CAI, a professional services firm dedicated to accelerating operational readiness and excellence in life sciences and mission-critical...
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. .