Validation Engineer

PSC Biotech•Augusta, GA

About The Position

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. We are hiring an experienced Validation Engineer to support equipment, process, and facility validation activities in a regulated life sciences environment. The Validation Engineer will play a key role in ensuring that all systems and equipment operate reliably, safely, and in compliance with cGMP and regulatory standards. This role involves 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.