Full-Time
Sterility Assurance Expert
Posted on 10/31/2025
CAI
501-1,000 employees
Operational readiness consulting for pharma
No salary listed
Italy
Hybrid
Travel throughout Italy and some European travel may be required.
 Biology & Biotech (7) |
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- Leads Sterility Assurance assessment in regulated manufacturing industry.
- Participates in cross functional projects, including customer meetings.
- Participates in the writing of protocols, reports, and specifications.
- Drives deliverables to completion with structured timelines.
- Execution of sterilizing equipment qualification.
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
501-1,000
Company Stage
Pre-seed
Total Funding
$3.4M
Headquarters
Indianapolis, Indiana
Founded
1996
Simplify's Take
What believers are saying
- JLL Partners investment expands CAI globally across four continents for 700 professionals.
- Fedegari partnership integrates turnkey sterilization, cutting biotech lifecycle costs.
- CAI's CQV services marked 30 years in 2026, accelerating facility compliance worldwide.
What critics are saying
- Oracle Life Sciences automates CQV with cloud platforms, eroding CAI's share in 12 months.
- Fedegari sells sterilization systems directly, capturing pharma clients in 18 months.
- JLL-mandated expansion dilutes CAI expertise, causing CQV failures in 24 months.
What makes CAI unique
- CAI specializes in commissioning, qualification, and validation for life sciences facilities.
- CAI delivers operational readiness assessments for biotech and pharma full-scale production.
- CAI pioneered neurodiversity hiring in enterprise consulting services.
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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