About the role

About CAI:

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.

Are you ready?

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.

Requirements Include

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)

Position Requirements

A bachelor’s degree or master's degree in chemical engineering, Biotech Engineering, Mechanical Engineering, Chemistry or Life Sciences, in the Pharmaceutical/Life Sciences industry. Engineering Consultancy (for Biopharma).

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

Skills & Tags

react go ai data design

Aplyr's read

CAI leverages cutting-edge AI and automation to streamline business processes, attracting skilled engineers and project managers in validation and commissioning roles.
Synthesized from recent postings & public sources

What's promising

•CAI focuses on AI-driven solutions, offering cutting-edge technology to enhance business efficiency.
•The company has a strong emphasis on hiring experienced engineers, indicating a commitment to technical excellence.
•CAI's involvement in data center projects highlights its role in critical infrastructure development.

What to watch

•Limited public information about CAI's financial stability and growth prospects.
•High concentration of roles in validation may limit opportunities for diverse career paths.
•Potential challenges in maintaining innovation pace in a rapidly evolving AI industry.

Why CAI

•CAI specializes in automation and AI, setting it apart in business process enhancement.
•The company is deeply involved in mission-critical data center projects, emphasizing its technical expertise.
•CAI's focus on validation and commissioning roles highlights its niche in quality assurance and project execution.

Aplyr’s read is generated by AI from public sources. Was it useful?

About CAI

CAI

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CAI is a company that specializes in providing advanced technology solutions, focusing on automation and artificial intelligence to enhance business processes.