Manish Baviskar | Pharmaceutical Validation Engineer

About Me

Experienced Pharmaceutical Validation Engineer with a strong background in FDA-regulated pharmaceutical manufacturing, computerized system validation, and capital project execution. Proven expertise in equipment, utility, process, and software validation (IQ/OQ/PQ/PPQ), regulatory compliance, and risk-based validation programs aligned with FDA, ISO, cGMP, GAMP 5, and ALCOA++ standards.

Demonstrated leadership in qualifying multiple manufacturing lines, leading cross-functional technical teams, and representing validation functions during regulatory inspections and audits. Strong record of supporting sterile and non-sterile operations, automated and AI-enabled systems, and end-to-end validation lifecycles across product development and commercial manufacturing environments.

Beyond validation engineering, I am actively engaged in research, with publications in peer-reviewed journals and patents in pharmaceutical sciences. My commitment to continuous learning and professional development drives me to stay at the forefront of industry best practices and emerging technologies, including AI and machine learning applications in pharmaceutical validation.

FDA Compliance

Expert in FDA 21 CFR Part 11 and cGMP regulations

Validation Expertise

IQ/OQ/PQ/PPQ, Risk-based Validation, FMEA

AI-Enabled Systems

Integration of AI/ML in pharmaceutical validation

Analytical Chemistry

HPLC, GC, and advanced analytical techniques

Professional Experience

Validation Engineer

Hubot CDMO/Tri-Pac, Inc South Bend, IN

February 26, 2024 – Present

Supervisor: Nirali Patel

Lead end-to-end capital projects, ensuring on-time delivery, cost efficiency, and compliance with GMP, OSHA, ISO 13485, and ISO 9001 standards
Quantified and validated 9 manufacturing lines for aerosol, liquid, and powder filling operations in alignment with cGMP and ALCOA++ principles
Process, Equipment, utility, process, Software and computerized system validation (IQ/OQ/PQ/PPQ) in FDA-regulated pharmaceutical environments, Develop and execute IQ, OQ, PQ protocols; generate validation summary reports
Developed and implemented a risk-based Validation Program integrated with FMEA, improving equipment reliability and reducing downtime (e.g. AI-enabled automated systems, computer system and software's)
Represented the validation department during FDA, ISO, and client audits; conducted gap analyses and updated SOPs, protocols, and FMEAs to meet current regulatory expectations
Conduct biweekly technical team meetings to monitor project updates and execution Provide status updates, perform gap analysis, FMEA, and ensure validation is ALCOA++ and cGMP compliant
Represent the Validation Department during regulatory inspections and audits (FDA, ISO, and customer), and serve as the primary Hubot CDMO point of contact with the U.S. Environmental Protection Agency (EPA) and the City of South Bend for pharmaceutical wastewater and environmental compliance management

Validation Specialist

Gill's Process Control, Inc Rocky Mount, NC

July 26, 2022 – December 29, 2023

Supervisor: Joey Parris

Led validation and commissioning of pharmaceutical and utility modification projects in compliance with FDA regulations, 21 CFR Part 11, and ISPE GAMP 5 guidelines
Developed complete validation lifecycle documentation including URS, FRS, DDS, SDS, and IQ/OQ/PQ protocols for GxP-compliant automated and manual systems
Performed Factory and Site Acceptance Testing (FAT/SAT), managed protocol execution, test scripting, data collection, and summary report generation for critical GMP systems
Collaborated with clients to lead validation assessments for proposed changes, performed risk-based evaluations, and ensured alignment with Good Automated Manufacturing Practice (GAMP)
Supported installation and qualification of pharmaceutical manufacturing systems such as sterilizers, isolators, HVAC systems, fillers, utility systems, and associated HMI interfaces
Delivered technical writing and document control support, ensuring accuracy and compliance of validation documents in alignment with SOPs and regulatory standards
Acted as Subject Matter Expert (SME) for C&Q and CSV documentation hierarchy, offering guidance across validation planning and change control processes

Validation Engineer

E-CQR, Inc Austin, TX

April 11, 2022 – July 15, 2022

Supervisor: Ravi Kumar

Provided validation engineering supporting both onsite and remotely for pharmaceutical manufacturing systems, ensuring timely execution and documentation of validation activities in compliance with cGMP, FDA 21 CFR Part 11, and ICH Q7/Q8 requirements
Assisted in the development, execution, and review of validation protocols (IQ/OQ/PQ) and final reports for critical GMP equipment, lab instruments, and computerized systems, maintaining traceability throughout the validation lifecycle
Reviewed and edited technical documentation, including validation Protocol, FAT/SAT summary reports, SOPs, and change controls, ensuring alignment with internal quality standards and client regulatory expectations

Quality Control Analyst (Analytical Chemist)

Carnegie Pharmaceuticals, LLC Delran, NJ

March 3, 2021 – April 8, 2022

Supervisor: Keval K Prasad

Performed routine and non-routine analytical testing on raw materials, in-process samples, and finished products using HPLC, GC, FTIR, UV-Vis, and wet chemistry techniques to ensure compliance with internal specifications and regulatory standards
Supported the execution of stability studies and method validation/verification for three generic drug products during development and scale-up. Prepared validation protocols and summarized data to support method lifecycle documentation
Supported new product development (NPD) and manufacturing operations by drafting, reviewing, and maintaining technical documentation including Product Evaluation Reports (PERs), Evaluation Batch Reports, Validation Protocols, and Preventive Maintenance (PM) documentation
Acted as a liaison between Quality Assurance, R&D, and Production departments to ensure accurate and timely communication of product performance and compliance metrics

QA/QC Associate

Quality CDMO Fort Worth, TX

January 4, 2021 – February 28, 2021

Supervisor: Poonam Jasani & Mayuriben Patel

Supported the initial establishment and operational startup of the Quality Control and Production departments in a newly launched CDMO facility, ensuring systems and processes aligned with FDA and ISO regulatory standards
Played a key role in equipment onboarding, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of critical laboratory and manufacturing equipment, including HPLC, GC, purified water systems, and production utilities

Lab Technician

AmSpec, LLC Pasadena, TX

May 20, 2019 – December 30, 2020

Supervisor: Brett Downs

Conducted testing of petroleum products, petrochemicals, and refinery intermediates in accordance with ASTM, UOP, and EPA standardized methods, including flash point, viscosity, density, distillation, sulfur content, RVP, and water content
Performed daily sample preparation activities, including homogenization, dilution, and filtration for both bulk and trace component analysis
Operated, calibrated, and maintained analytical instruments including Gas Chromatography (GC), Density Meter, Flash Point Tester (Pensky-Martens & Abel), Viscosity Baths, Auto-Titrators, and Distillation Units
Reviewed and cross-checked test data for accuracy and integrity prior to final reporting; flagged discrepancies and initiated corrective actions when necessary
Actively contributed to continuous improvement efforts by identifying inefficiencies in workflow and suggesting enhancements to streamline sample throughput and reporting timelines

Quality Control Investigator

AmerisourceBergen Sugar Land, TX

April 22, 2019 – May 19, 2019

Supervisor: Kelvin Kulesza

Investigated product quality complaints, manufacturing deviations, and laboratory discrepancies in compliance with cGMP and FDA regulations
Executed root cause analyses using tools such as 5 Whys, Fishbone Diagrams, and Ishikawa methods to identify sources of process failures or non-conformities
Supported data review for batch release by evaluating batch records, test reports, and equipment logs

Analytical Chemist

A & B Environmental Services, Inc Houston, TX

March 18, 2019 – May 14, 2019

Supervisor: Janardhan Dongre

Maintained strict adherence to EPA Method guidelines (e.g., EPA 6010, 6020, 8260, 8270) for sample collection, preparation, and testing
Operated and calibrated analytical instrumentation performed preventative maintenance, and documented performance checks to ensure data reliability and accuracy
Interpreted chromatograms and spectral data, ensuring compliance with project-specific reporting limits and regulatory criteria

Quality Control Analytical Chemist

Woodfield Pharmaceutical, LLC Houston, TX

October 1, 2018 – February 13, 2019

Supervisor: Orlando Arroyo

Managed Notice of Events (NOEs) and initiated quality investigations for laboratory deviations, equipment malfunctions, and procedural non-compliance in alignment with cGMP and internal SOPs
Authored and implemented Corrective and Preventive Actions (CAPAs) to address recurring issues, improve laboratory practices, and enhance product quality assurance processes
Coordinated Customer Complaint Investigations, including batch history review, retention sample analysis, and trend evaluation to determine complaint validity and root cause
Collaborated with Quality Assurance, Production, and Regulatory teams to ensure timely closure of complaints and deviations while maintaining regulatory compliance with FDA and ICH Q10 expectations
Participated in internal audits and supported regulatory inspections by providing investigation histories, complaint logs, and associated documentation

Education

Generative AI Overview for Project Managers

Project Management Institute

Issued October 2024

Good Documentation Practice and Data Integrity-ALCOA

Velocity 360 Training

Issued June 2024

Credential ID: 104152794

Pharmaceutical - CGMP and ISO 13485 Lead Auditor

Velocity 360 Training

Issued June 2024

Credential ID: 106717860

Skills

Validation & Compliance

IQ/OQ/PQ/PPQ

Risk-based Validation

FMEA

cGMP

FDA 21 CFR Part 11

GAMP 5

Computerized System Validation

ALCOA++

Analytical Chemistry

HPLC

Spectroscopy

Technology & Tools

AI/Machine Learning

Project Management

Data Analysis

Research, Publications & Patents

Risk-Based Validation of Software, Automation and Artificial Intelligence in Pharmaceuticals

Manish Baviskar

Biosciences Biotechnology Research Asia, Vol. 22(4), 2025

Published Read Paper

Potential of Magnetotactic Bacteria for the Fabrication of Iron Nanoparticles

Manish Baviskar (Co-author)

TMS 2017 – 146th Annual Meeting & Exhibition Supplemental Proceedings, 2017

Published

Polyherbal Loaded Nano Emulsion Gel Intended for Topical Route: Design, Development, and Evaluation for Psoriasis Treatment

Manish Baviskar (Co-author)

Lamar University

May 2018

Completed M.S. thesis titled "Microbial Analysis and Isolation of Iron-Reducing Bacteria from the Marquez Impact Crater, Texas, USA," forming the basis for subsequent peer-reviewed research and conference presentations.

Honors & Awards

Invited Guest Speaker

MET Institute of Pharmacy, Nashik

September 2025

Delivered invited lecture on "Integration of AI in Pharmaceuticals"

Editorial Manager & Peer Reviewer

Journal of Strategy & Innovation (ISSN: 3050-7901)

November 2025 - Ongoing

Ongoing editorial and manuscript evaluation responsibilities

Peer Reviewer

Pharmacotherapy (ISSN: 1875-9114)

September 2025 - Ongoing

Formal editorial service contributing to scholarly quality control

NASA Astrobiology Graduate Conference Presentation

AbGradCon, Georgia Institute of Technology

June 2018

Presented "Geochemical and Geophysical Gradients from a Meteoroid Impact Result in a Unique Pattern of Microbial Distribution"

Invited Participant - NASA Proposal Writing Retreat

NASA-Supported Proposal Writing Retreat

June 2017

Selected for NASA-supported Proposal Writing Retreat (June 2–5, 2017)

Third Place - Graduate Division

7th Annual Departmental Student Research Poster Competition, Lamar University

October 2017

Research Poster Competition

First Place - Graduate Division

6th Annual Departmental Student Research Poster Competition, Lamar University

September 2016

Recognizing excellence in graduate-level research and scientific communication

Invited Lecture

Indo-Europe Educational Program – International Conference on Biodiversity

January 2015

Delivered invited lecture on "Eutrophication and Environmental Impact"

Oral Presentation

7th International Congress of Environmental Research (ICER-14), Bangalore, Karnataka, India

December 2014

Delivered oral research presentation addressing environmental research themes

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Pharmaceutical Validation Engineer

About Me

FDA Compliance

Validation Expertise

AI-Enabled Systems

Analytical Chemistry

Professional Experience

Validation Engineer

Validation Specialist

Validation Engineer

Quality Control Analyst (Analytical Chemist)

QA/QC Associate

Lab Technician

Quality Control Investigator

Analytical Chemist

Quality Control Analytical Chemist

Education

Master of Science (M.S.) – Chemistry

Master of Science (M.S.) – Microbiology

Bachelor of Science (B.Sc.) – Microbiology

Diploma in Business Management

Diploma in Bioinformatics

Training & Certifications

Machine Learning: Modern Computer Vision & Generative AI

Generative AI Overview for Project Managers

Good Documentation Practice and Data Integrity-ALCOA

Pharmaceutical - CGMP and ISO 13485 Lead Auditor

Skills

Validation & Compliance

Analytical Chemistry

Technology & Tools

Research, Publications & Patents

Risk-Based Validation of Software, Automation and Artificial Intelligence in Pharmaceuticals

Potential of Magnetotactic Bacteria for the Fabrication of Iron Nanoparticles

Polyherbal Loaded Nano Emulsion Gel Intended for Topical Route: Design, Development, and Evaluation for Psoriasis Treatment

Development and Optimization of Polyglutamic Acid Enriched Lip Balm Using Experimental Design Approach

AI-Powered Microbial Sampling and Profiling Device

Livestock Stress Monitoring Device with Relief System

AI-Based Dermatoscope

Bio-Fingerprinting and Auto-Formulation Device (BioFormID®)

Multi-Parameter Analytical Scanner (QualiScan®)

Real-Time Medicine Verification Tool

AI-Controlled Intravenous Fluid Infusion Device

Graduate Research Assistant

Master's Thesis Research

Honors & Awards

Invited Guest Speaker

Editorial Manager & Peer Reviewer

Peer Reviewer

NASA Astrobiology Graduate Conference Presentation

Invited Participant - NASA Proposal Writing Retreat

Third Place - Graduate Division

First Place - Graduate Division

Invited Lecture

Oral Presentation

Professional Memberships

American Association of Pharmaceutical Scientists (AAPS)

Project Management Institute (PMI)

Reference

Google Scholar

ResearchGate

ORCID

Academia.edu

GitHub Repository

GitHub Repository

Research Publication

Get In Touch

Contact Information

Location

Phone

Email

LinkedIn