About the role
CAI was established in 1996; it has grown year over year to more than 750 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
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.
We strongly believe that one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
Led end-to-end CQV and CSV lifecycle activities, including URS, risk assessments, IQ/OQ/PQ execution, and final reporting for GMP-regulated environments.
Executed risk-based validation strategies compliant with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
Managed Commissioning of Plant Utilities, Commissioning and qualification of clean utilities, process equipment, HVAC systems, Automation and computerized systems for Biotech API and Fill Finish facilities.
Experienced in commissioning, qualification, and validation of Water Systems (PW/WFI), CIP/SIP systems, autoclaves, bioreactors, nitrogen and process air systems.
Demonstrated knowledge of upstream and downstream manufacturing equipment qualification, supporting GMP-compliant project execution throughout the equipment and utility lifecycle.
Developed and reviewed validation documentation including VMPs, SOPs, RTMs, protocols, and summary reports.
Performed FAT, SAT, commissioning, and shakedown testing ensuring seamless transition into qualification phases.
Utilized platforms like Kneat / Veeva / TrackWise for electronic validation lifecycle management.
Conducted GxP impact assessments, data integrity risk assessments, and FMEA analyses to define validation scope.
Collaborated cross-functionally with QA, Engineering, IT, and Vendors to deliver projects on schedule.
Managed deviations, CAPA, and change controls ensuring audit-ready documentation at all stages.
Mentored junior engineers on CQV/CSV best practices and regulatory expectations.
1. Deviation handling
2. IQ/OQ/PQ execution
3. Audit findings and responses
Knowledge on Regulatory frameworks (FDA, ICH, EU, MHRA, GAMP 5, ISPE, ASME BPE)
Core Focus Areas:
Commissioning, Qualification & Validation (CQV)
Regulatory compliance (FDA, ICH, GAMP 5)
Commissioning of Plant Utilities and Integration and Handshake with other systems, Clean Utilities, HVAC (CIP, SIP, WFI system, Part Washer and HVAC system and manufacturing process equip)
Equipment & system qualification (HVAC, Clean Utilities, manufacturing Process systems)
Documentation, execution, and lifecycle validation
Key Responsibilities:
Develop and execute CQV/CSV validation strategies
Prepare and review IQ, OQ, PQ protocols and reports
Perform risk assessments (FMEA, GxP, data integrity)
Support design reviews, FAT/SAT, commissioning activities
Collaborate with Project, QA, Engineering, Manufacturing, IT, System Vendors
Maintain audit-ready documentation
Use tools like Kneat, Veeva, TrackWise
Ensure compliance with:
1. FDA 21 CFR Part 11
2. EU Annex 11
3. ICH Q8/Q9/Q10
4. GAMP 5
5. ISPE Guideline
Lead/mentor junior team members
Manage timelines, stakeholders, and project execution
