Validation Engineer

Kathryn M. Spaulding

Validation Engineer 810-***-**** ********@***.***

OBJECTIVE

A dedicated Validation Engineer with a proven track record in pharmaceutical manufacturing. Proficient in the development of validation protocols and the application of good documentation practices in accordance with cGMP standards. A self-motivated professional known for meticulous attention to detail, effective time management, and a strong commitment to continuous improvement.

WORK EXPERIENCE

Senior Validation Engineer Biovire, Inc (formerly Bryllan LLC) Brighton, MI April 2023 – Current

Established and built validation programs as the site’s first validation engineer, creating processes for the qualification of pharmaceutical equipment.

Authored and implemented SOPs to improve consistency and efficiency, including development of a requalification program for maintaining validated systems.

Led validation activities for equipment and processes, including IQ/OQ/PQ protocols, ensuring compliance with regulatory requirements and internal quality standards.

Played a key role in continuous improvement activities, contributing to six out of seven cross-functional workstreams.

Led the Qualification/Validation FDA Readiness Team, driving inspection preparedness activities.

Coordinated and directed the work of contractors to support validation deliverables, timelines, and documentation quality.

Provided guidance and oversight to an additional validation engineer, supporting workload management and technical development.

Collaborated with cross-functional teams including quality, engineering, and operations to resolve issues and improve process reliability.

Managed competing priorities in a fast-paced environment, quickly expanding scope of responsibility and adapting to evolving business needs.

Maintained up-to-date knowledge of Standard Operating Procedures (SOPs) and industry learning materials.

Maintained meticulous organization and documentation of all qualification documents to establish and uphold a comprehensive validation library.

Ensured accurate records of pharmaceutical equipment and its qualification status were consistently updated.

Validation Engineer Performance Validation Portage, MI September 2021 – March 2023

Applied industry, regulatory, and client-specific knowledge to develop validation documents, including Risk Assessments and IQ/OQ/PQ Protocols

Acquired expertise in the operation of new equipment, instrumentation, methods, and processes.

Executed validation activities, ensuring compliance with established protocols and cGMP standards.

Applied good documentation practices in the execution of protocols and procedures.

SKILLS

Highly self-motivated

Strong attention to detail and highly organized

Ability to prioritize multiple tasks effectively

Ability to work autonomously or within a team

Effective written and verbal communication skills

Advanced proficiency in Microsoft Office suite

EDUCATION

Bachelor of science Michigan Technological University Houghton, MI

Major: Biomedical Engineering

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