Associate Validation Engineer - VA

Role Summary

Associate Validation Engineer - VA

Responsibilities

• 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

Qualifications

• Bachelor‚Äôs Degree in Life Science, Engineering, or relevant field of study from an accredited required
• In lieu of Bachelor‚Äôs 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

Skills

• Validation and qualification execution
• Documentation and data analysis
• Cross-functional collaboration

Education

• Bachelor‚Äôs Degree in Life Science, Engineering, or relevant field of study (required) or an Associate‚Äôs Degree with additional validation experience

Additional Requirements

• Ability to travel up to 10% of the time
• Move equipment and supplies up to 33 pounds; ability to work up to 12-hour shifts