Quality & Validation Engineer

Position : Quality & Validation Engineer

Location : Petersburg, VA

Experience : 5+ Years

Position Overview :

The Quality & Validation Engineer is responsible for performing validation activities, including DQ, IQ, OQ, PQ, and Requalification. This role acts as a Subject Matter Expert (SME) in validation, ensuring a science- and risk-based approach when defining project strategies. The incumbent ensures that the validated state of facilities, utilities, systems, and equipment is maintained in compliance with regulatory and quality standards.

Key Responsibilities :

Author and review validation plans and documents to ensure compliance with requirements.

Ensure adherence to quality and regulatory standards for validation of facilities, utilities, computerized equipment, and laboratory equipment.

Present validation documents and strategies during internal audits and external inspections.

Maintain regulatory documentation related to changes in the validated state.

Perform revalidations, system evaluations, and continued process verification schedules.

Independently analyze and interpret data, make tactical decisions, and develop project strategies with minimal supervision.

Represent Validation on cross-functional teams including Engineering, Technical Support, and Quality.

Follow all safety and environmental requirements.

Perform other duties as assigned.

Physical Requirements :

Ability to move equipment or supplies weighing up to 33 pounds.

Operate and inspect manufacturing equipment manually.

Stand for up to 12 hours per shift.

May require corrected vision (20 / 20 or 20 / 25) and color vision depending on role.

Occasional climbing, working at elevated heights, or within confined spaces.

May work around hazardous or odorous materials.

Ability to work in loud environments with hearing protection.

Ability to travel up to 10% of the time.

Qualifications :

Bachelor's degree in Life Sciences, Engineering, or a related field with a minimum of five years of validation experience in a cGMP-regulated industry OR

Associate's degree in Life Sciences, Engineering, or a related field with a minimum of seven years of validation experience in a cGMP-regulated industry.

Strong understanding of GEP and validation concepts, international cGMP regulations, and industry standards for facilities, utilities, systems, and equipment.

Excellent verbal and written communication skills.

Self-motivated, trustworthy, team-oriented, innovative, and able to work in a fast-paced environment.