Validation Engineer II - Virginia

Role Summary

Validation Engineer II is responsible for performing validation activities (DQ, IQ, OQ, PQ and Requalification), acting as a validation SME to define project strategy with a science- and risk-based approach, and ensuring the validated state of facilities, utilities, systems, and equipment is maintained.

Responsibilities

• Author validation plans and review/approve validation documents to ensure that requirements are met
• Ensure adherence to quality and regulatory requirements for validation of facilities, utilities, computerized equipment, laboratory equipment, as required
• Present validation documents and strategy in internal audits and external inspections
• Maintain regulatory documentation as it relates to changes in the validated state
• Perform revalidations, system evaluations, and continued process verification schedules
• Independently analyze and interpret data with limited consultation with supervisor, make independent tactical decisions based on data, and develop project strategies with consultation with supervisor
• Represent Validation on cross-functional teams (Engineering, Technical Support and Quality groups)
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

Qualifications

• Bachelor’s Degree in Life Sciences, Engineering, or a relevant field of study from an accredited university required with a minimum of five (5) years of validation experience in a cGMP regulated industry
• In lieu of BS degree + five (5) years of validation experience in a cGMP regulated industry, may consider an Associate’s degree in Life Sciences, Engineering, or a relevant field of study from an accredited university with a minimum of seven (7) years of validation experience in a cGMP regulated industry
• Demonstrated understanding of GEP and Validation concepts, international cGMP regulations, and industry standards pertaining to the technical and verification requirements for facilities, utilities, systems and equipment
• Excellent communication skills; both written and verbal
• Demonstrated ability to be self-motivated, trustworthy, work in a high-paced environment, team oriented, innovative, and committed

Skills

• Validation planning and document review
• Regulatory compliance and quality assurance
• Data analysis and decision making
• Cross-functional collaboration
• Communication (written and verbal)

Education

• Bachelor’s Degree in Life Sciences, Engineering, or a relevant field (required) or an Associate’s degree with additional experience as specified

Additional Requirements

• Ability to travel up to 10% of the time