Chetan Kawale

Results-driven Computer System Validation (CSV) and Computer Software Assurance (CSA) leader with 12+ years of experience in pharmaceutical and life sciences environments. Expertise in SCADA validation, Serialization and Track & Trace systems, validation lifecycle management, regulatory compliance, and team leadership. Delivered 100+ validation projects globally and managed teams of up to 10 professionals.

Recognized for developing master documentation frameworks and automating validation documentation processes.

Deputy Manager – Validation Documents - Glatt Systems Pvt. Ltd.

(2024-03)

• Lead validation documentation strategy, planning, and execution.
• Developed automated document preparation tools that significantly reduced document generation effort, improved standardization, and accelerated project delivery timelines.
• Manage validation resources, customer interactions, FAT/SAT support, and compliance deliverables.
• Drive regulatory compliance with GAMP 5, 21 CFR Part 11, and Data Integrity requirements.

Validation Specialist - TraceLink

(2023-10 - 2024-02)

• Executed software validation, lifecycle activities and documentation.
• Prepared FRA, Traceability Matrix, VSR, and validation protocols.
• Performed RCA and supported validated software releases.

Team Lead – Validation Documents & CSV - ACG Engineering Pvt. Ltd.

(2017-12 - 2023-10)

• Led CSV and qualification activities for pharmaceutical projects.
• Designed and implemented a Master Documentation Framework that standardized validation deliverables across multiple projects, improving consistency, compliance, and document preparation efficiency.
• Managed validation teams and customer-facing technical discussions.
• Prepared and reviewed FS, FRS, DQ, IQ, OQ, FAT, SAT, and compliance documentation.

Senior Engineer – Technical Documents - Glatt Systems Pvt. Ltd.

(2015-07 - 2017-11)

• Prepared qualification protocols and validation documentation.
• Supported FAT, SAT, compliance activities, and customer interactions.

Senior Engineer – Technical Documents - Gansons Ltd.

(2015-02 - 2015-07)

• Prepared DQ/IQ/OQ documentation and technical reports.
• Supported FAT/SAT and qualification activities.

Senior Engineer – Technical Documents - Adam Fabriwerk Pvt. Ltd.

(2013-09 - 2014-09)

• Prepared DQ/IQ/OQ documentation and technical reports.
• Supported FAT/SAT and qualification activities.

Bachelor of Engineering - Mechanical Engineering - Amrutvahini College of Engineering, Sangamner (2013)

HSC - RYK College of Science, Nasik (2008)

SSC - Adarsh Madhyamik Vidyalay, Nasik (2006)