Validation Engineer II - Virginia
Novo Nordisk
Full-time
Remote friendly (Petersburg, VA)
United States
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Role Summary
Validation Engineer II - Virginia. Responsible for performing validation activities (DQ, IQ, OQ, PQ, and Requalification) and acting as a validation SME to define strategy for projects. Ensure the validated state of the facility, utilities, systems, and equipment is maintained.
Responsibilities
- Author validation plans and review/approve validation documents to ensure 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
- Self-motivated, trustworthy, able to work in a high-paced environment, team oriented, innovative, and committed
Skills
- Validation planning and document control
- Data analysis and decision making with limited supervision
- Cross-functional collaboration (Engineering, Technical Support, Quality)
- Regulatory and quality requirements in cGMP environments
Education
- Bachelor’s Degree in Life Sciences or Engineering (or relevant field) required; alternative: Associate’s degree with additional years of validation experience as listed
Additional Requirements
- Ability to travel up to 10% of the time
- Physical requirements as described in the job description may apply