Validation Engineer II - Virginia

Role Summary

Validation Engineer II based in Petersburg, Virginia, responsible for performing validation activities (DQ, IQ, OQ, PQ and requalification) and serving as a validation SME. Applies a science- and risk-based validation approach to define project strategy and ensures 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

Additional Requirements

• Moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions
• Routinely operates and inspects manufacturing equipment using hands
• Strap and unstrap pallets using hands
• Must be able to be on your feet for up to a 12-hour shift
• May require corrected vision to 20/20 or 20/25
• May require color vision
• Occasionally ascends/descends ladders; may be required to work at elevated heights
• Occasionally works around odorous or hazardous materials
• May be required to wear latex gloves
• May perform critical job functions in extremely cold work environments
• May position oneself within confined spaces for inspection
• Ability to work in loud noise environments with hearing protection
• May be required to secure a motorized vehicle license and operate a motorized vehicle
• Ability to travel up to 10% of the time