Quality Engineer

2 weeks ago


Hamilton, United States Premier Life Sciences LLC Full time

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 areas
  • Consults 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 team
  • Participates 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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