Colby Lane
Ocala
Summary
Validation engineer with expertise in qualification processes and regulatory compliance. Demonstrated problem-solving abilities and effective communication skills led to high-quality outcomes in pharmaceutical settings. Committed to upholding rigorous standards in validation and documentation. Over four years of experience providing validation consulting services in pharmaceutical and biotechnology sectors.
Overview
4
4
years of professional experience
Work History
Validation Engineer II
CAI
03.2023 - Current
- Executed validation efforts for new and existing GMP facilities, integrating technical expertise with project coordination.
- Managed qualification processes for critical utilities including WFI, AWFI, CCA, CO2, N2, and O2.
- Authored and executed Commissioning/IQ/OQ/PQ protocols for various equipment and systems.
- Authored URS and SIAs for various systems and equipment.
- Supported deviation resolution while creating summary reports to maintain regulatory compliance.
- Facilitated seamless turnover of systems for production readiness through effective communication.
- Performed temperature mapping on cold rooms and warehouses.
Validation Specialist
Valsource
Rensselaer
02.2022 - 03.2023
- Developed and executed validation protocols, ensuring adherence to regulatory compliance and industry standards.
- Conducted validation activities for equipment and processes to ensure operational integrity in pharmaceutical environments.
- Executed cleaning validation and verification tasks to maintain compliance with standard operating procedures.
Education
Bachelor of Science - Biology
University At Albany
Albany, NY12-2021
Associate of Science - General Science
SUNY Columbia-Greene
Hudson, NY06-2018
Skills
- Validation protocols
- Equipment qualification
- GMP compliance
- FDA regulations
- ISO standards
- Good manufacturing practices
- Validation documentation
- Deviation resolution
- Temperature mapping
- Data integrity
- Pharmaceutical industry understanding
- Pharmaceutical standards
- Record keeping
Timeline
Validation Engineer II
CAI
03.2023 - Current
Validation Specialist
Valsource
02.2022 - 03.2023
Bachelor of Science - Biology
University At Albany
Associate of Science - General Science
SUNY Columbia-Greene