Associate Validation Engineer
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Petersburg • Virginia • 🇺🇸 United States
Visit company websiteJob Level
JuniorMid-Level
About the role
- Responsible perform validation activities such as DQ, IQ, OQ, PQ and Requalification.
- Responsible for ensuring that the validated state of the facility, utilities, systems, and equipment are maintained.
- Perform temperature mapping of systems in all process conditions (ambient, ultra-cold, etc.) as well as perform simple troubleshooting related to temperature mapping and controlled chambers
- Support leadership in performing equipment installation qualification, operational qualification, performance qualification and requalification in accordance with validation procedures
- Responsible for generating protocols, executing validations, analyzing data, generating reports, identifying validation deviations, resolving validation deviations with support from Sr Project Manager, and engaging in investigations to identify root causes and defining corrective/preventative actions
- Assist with validation documentation such as URS, risk assessments, design reviews, and reports when necessary
- Maintain training programs for validation contractors with support from SME as well as deploy test equipment training to equipment users
- Maintain system evaluations to ensure systems are staying within the validated state
- Maintain validation and process engineering test equipment within computerized maintenance system and ensure test equipment is calibrated timely and always readily available
- Work on cross-functional teams with Validation, Engineering, Manufacturing, Project Management, Quality Control, Facilities, and Quality Assurance
- Follow all safety & environmental requirements in the performance of duties
- Other duties as assigned
Requirements
- Bachelor’s Degree in Life Science, Engineering, or relevant field of study from an accredited required
- In lieu of Bachelor’s Degree, may consider Associates Degree in Life Sciences, Engineering, or a relevant field of study from an accredited university required and a minimum of two (2) years of validation experience in a cGMP regulated industry required
- Demonstrated ability to follow routine work instructions for new and ongoing projects and assignments required
- Excellent communication skills; both written and verbal required
- Demonstrated ability to be self-motivated, trustworthy, work in a high-paced environment, team oriented, innovative, and committed required
Benefits
- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including 14 paid holidays
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
validation activitiesDQIQOQPQtemperature mappingtroubleshootingprotocol generationdata analysiscalibration
Soft skills
communication skillsself-motivatedtrustworthyteam orientedinnovativecommitted