Summary
Overview
Work History
Education
Skills
Timeline
Generic

Sujal Patel

Morrisville,NC

Summary

Overall 12+ years of experience in Commissioning, Qualification and Validation (CQV) within cGMP biopharmaceutical manufacturing facilities, including 3+ years supporting Greenfield biologics startup (Project Galaxy) at FUJIFILM Diosynth Biotechnologies. Currently serving as Acting Process Support Equipment (PSE) CQV Lead, providing technical direction, lifecycle validation strategy, and team leadership for large CAPEX manufacturing programs. Strong experience in validation lifecycle management (VMP, URS, RTM, DQ, IOQ, PQ), risk-based validation strategies, and maintaining equipment in a validated and inspection-ready state. Recognized for people leadership, problem solving, cross-functional collaboration, and delivering projects on time and within budget.

Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.

Results-driven individual with a solid track record in delivering quality work. Known for excellent communication and teamwork abilities, with a commitment to achieving company goals and delivering exceptional service. Passionate about continuous learning and professional development.

Overview

4
4
years of professional experience

Work History

Senior Validation Engineer / Acting PSE CQV Lead

FUJIFILM Diosynth Biotechnologies
Holly Springs, USA
06.2022 - Current
  • Provide strategic and technical leadership for Process Support Equipment (PSE) CQV program supporting ~80% completion of Project Galaxy Greenfield biologics facility.
  • Lead commissioning and qualification activities from design review through Performance Qualification (PQ) and commercial readiness.
  • Oversee validation lifecycle documentation including VMP, VPP, URS, RTM, DQ, QRA, IOQ, and PQ protocols and summary reports.
  • Manage and mentor team of 15 CQV engineers; provide workload prioritization, milestone tracking, and performance feedback.
  • Drive project goals to ensure successful completion of project phases through commercial manufacturing.
  • Develop Post-Autoclave Hold Time (PAHT) PQ strategy using risk-based worst-case load identification.
  • Design Direct Impact and Simple Direct Impact CQV execution models to optimize validation efficiency.
  • Partner with Process Engineering, Automation, QA, QC, Manufacturing, and Global Engineering teams.
  • Support FAT and SAT activities ensuring compliance with URS and GMP requirements.
  • Provide technical oversight of deviations, change controls, CAPAs, and requalification activities.
  • Ensure PSE systems remain in validated state and inspection-ready at all times.
  • Present validation strategy updates and risk mitigation plans to senior leadership.

Senior Specialist Engineer

Merck
Wilson, USA
  • Led equipment qualification and cleaning/sterilization validation programs for BFS systems, Vial Fillers, Lyophilizers, Autoclaves, Depyrogenation Ovens, and CTUs.
  • Supported tech transfer and facility expansion projects.

Validation Lead II

Sanofi Pasteur
Swiftwater, USA
  • Led equipment and process validation programs supporting sterile vaccine manufacturing.
  • Managed cross-functional coordination and validation documentation lifecycle.

Validation Engineer

Merck
West Point, USA
  • Executed sterilization validation, cleaning validation, and equipment qualification for aseptic manufacturing systems.

Education

Master of Science - Pharmaceutical Manufacturing Engineering & Validation

Stevens Institute of Technology
Hoboken, NJ

Bachelor of Science - Pharmacy

The Oxford College of Pharmacy
Bangalore, India

Skills

  • Process Support Equipment (PSE) CQV Leadership
  • Equipment Qualification (IQ, OQ, PQ)
  • Validation Master Planning (VMP) & Lifecycle Strategy
  • Greenfield & Large CAPEX Program Execution
  • Team Leadership & Mentoring
  • Risk Management (FMEA, QRM)
  • Cleaning & Sterilization Validation (CIP/SIP)
  • Autoclaves
  • Parts Washers
  • IBC Washers
  • BSCs
  • Laminar Flow Hoods
  • Sampling Booths
  • CTU Qualification & Temperature Mapping
  • Regulatory Compliance (FDA, cGMP, 21 CFR Part 11)
  • Deviation
  • Change Control
  • CAPA Oversight
  • Cross-Functional Stakeholder Management
  • Budget & Schedule Tracking

Timeline

Senior Validation Engineer / Acting PSE CQV Lead

FUJIFILM Diosynth Biotechnologies
06.2022 - Current

Senior Specialist Engineer

Merck

Validation Lead II

Sanofi Pasteur

Validation Engineer

Merck

Master of Science - Pharmaceutical Manufacturing Engineering & Validation

Stevens Institute of Technology

Bachelor of Science - Pharmacy

The Oxford College of Pharmacy
Sujal Patel