Validation Engineer

PSC Biotech•Augusta, GA

20h

About The Position

PSC Biotech provides essential services to the life sciences industry, ensuring health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. The company aims to help clients achieve success globally with a multi-cultural team across North America, Europe, Asia, and the Middle East. PSC Biotech is passionate about bringing together skilled professionals, offering an inspiring career environment where employees can explore professional passions and work alongside a team that values their talents. The company believes in coaching and developing future industry leaders, providing compensation, benefits, and tools for growth and learning. PSC Biotech is hiring an experienced Validation Engineer to support equipment, process, and facility validation activities in a regulated life sciences environment. This role is key to ensuring all systems and equipment operate reliably, safely, and in compliance with cGMP and regulatory standards, involving planning, writing, implementing, and executing validation protocols to ensure consistent product quality and regulatory compliance.

Requirements

Bachelor’s degree in Engineering (Mechanical, Chemical, or related field) or Life Sciences.
3–5 years of validation experience within the pharmaceutical, biotech, or medical device industries.
Strong knowledge of equipment and process validation in FDA -regulated environments.
Familiarity with industry standards such as ASTM E2500, ISPE Baseline Guides, and cGMP regulations.
Experience with cleanroom systems, HVAC, purified water, compressed air, and other critical utilities.
Proficiency in writing and executing IQ/OQ/PQ protocols and validation reports.
Strong analytical and problem -solving skills.
Excellent written and verbal communication abilities.
Strong time management and organizational skills.
Detail -oriented mindset with a commitment to maintaining high -quality standards.
Must be authorized to work in the US.
No C2C at this time.

Responsibilities

Perform execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Generate and execute validation documentation for equipment, utilities, and processes in accordance with cGMP and GxP standards.
Support commissioning and qualification (CQV) activities for new and existing systems.
Ensure seamless integration and validation of manufacturing equipment and facility systems.
Troubleshoot and resolve issues related to validated equipment and processes, implementing corrective and preventive actions (CAPA) as needed.
Additional responsibilities as assigned to drive project success.