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Quality Engineer - Sterling, United States - Premier Life Sciences LLC
Description
Job Title:
Validation Engineer Across the USA
Has understanding of regulations pertaining to the implementation and use of computerized systems in all GxP areas.
Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5.
Reviews and approves system lifecycle deliverables for new and modifications to computerized systems used in the GxP areasConsults with QISM team members and relevant internal stakeholders to identify / define high risk areas with the intent on focusing on patient safety, product quality and data integrity.
Identifies and escalates areas of risk or non-compliance to manager / leadership teamParticipates in performing Periodic Review activities of Computerized Systems
Provide support to regulatory inspection preparedness activities as needed
Experience performing Infrastructure Qualification activities
Requirements
Youve earned your BS in chemical, biomedical, or biochemical engineering, biological sciences, or related field/experience.
Experience quality assurance tasks and remediation actives.
Experience reviewing Master Batch Records and validation documents.
Required Skills:
4 years plus of equipment validation experience in a pharma/GMP environment, must have:
Temperature mapping
Chamber requalification
Clean utilities experience
Validation experience with HVAC, Utilities, and Vial filling line equipment
Hands on experience with terminal sterilization and aseptic processing
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