Validation Engineer

CSV Bethesda, Maryland


Description

We at Azzur Group are looking for a Validation Engineer to immediately join our Azzur Consulting: Philly Team. The Validation Engineer is an FTE project based role. The role is broken down into two primary focuses. 

Responsibilities:
The first primary focus of this role will be to assess all active equipment and computer systems’ current GMP compliant validated status through a formal periodic review documentation process.

  • Provide support of QA validation functions.
  • Perform Periodic Review activities for all facility/utility, equipment, and computer systems.
  • Provide ongoing validation recommendations for requested changes or modifications to existing validated equipment and computer systems.
  • Provide technical support on change controls and other changes proposed necessary to maintain a validated status.
  • Provide quality oversight of facility/utility, equipment, and computer systems for qualification activities.
  • Review of all documents (URS, FRS, IQ, OQ, PQ) generation in support of qualification/ validation of systems.
  • Support all validation-related pre-inspection readiness initiatives and activities.
  • Participate in discrepancy/deviation investigations and implement corrective/preventive action.
  • Provide technical assessments on change controls, deviations, and investigations.
The second primary focus of this role will be to perform assessments and execute remediation activities for all computer and quality management systems.
  • Perform data integrity assessments for equipment, computer systems, and Enterprise computer systems.
  • Provide technical support on requalification activities for equipment and computer systems, including the creation of System Impact Assessments, System Criticality Assessments, and User Requirement Specifications.
  • Generate risk assessments to identify high risk equipment/ systems and implementation of corrective action.
  • Develop and/or update computer system governance documents according to current applicable regulatory requirements– including system administration, access management, change management, data backup, disaster recovery and business continuity.
  • Author audit trail review documents and execute for computer systems.
  • Support all validation-related pre-inspection readiness initiatives and activities.
  • Provide ongoing validation recommendations for requested changes or modifications to existing validated equipment and computer systems.
  • Participate in discrepancy/deviation investigations and implement corrective/preventive action.
  • Provide technical assessments on change controls, deviations, and investigations.
Experience:
  • Minimum 5 years industry related experience
  • Minimum 5 years of direct GMP experience
  • Must have strong knowledge of 21 CFR, ICH Q9 & ICH Q10, GAMP and EU regulations.

Azzur Group partners with leading pharmaceutical, biotechnology, and medical device manufacturers to provide efficient and innovative solutions that help them start, scale, and sustain their GxP organizations. With experts at more than 15 locations throughout the United States we take pride in our development and execution of phase-appropriate quality and compliance services to our clients From Discovery To DeliveryTM. 

Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. 

#LI-AS1