Senior Principal Validation Engineer

Company: EPM Scientific - Phaidon International
Location: Albuquerque
Posted on: March 20, 2025

Job Description:

We have a current opportunity for a Senior Principal Validation Engineer on a permanent basis with a rapidly expanding global organization based in Albuquerque, NM. This position will play a critical role in the expansion including other key projects for this site. If interested, please see the below!Key Responsibilities

• Manage projects and daily activities: Oversee validation activities, review change controls, maintain validated equipment, and update validation documents.
• Collaborate with departments: Ensure timely completion of risk assessments and validation activities for new components, equipment, systems, and utilities.
• Support new product introductions: Manage equipment re-qualification schedules and ensure plant readiness after shutdowns.
• Work with engineering and facilities: Ensure proper system installation and operation, and provide technical support for validated systems.
• Develop and execute protocols: Complete reports for equipment, processes, utilities, and revalidations.
• Write Standard Operating Procedures (SOPs): Create SOPs for new processes and equipment.
• Assist with department projects: Support engineers, calibrations, and validations on ongoing projects.
• Support audits: Provide and present data for internal and external audits.
• Ensure compliance: Follow current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDPs).
• Review and write validation documents: Prepare validation protocols, final reports, and summaries for equipment release.
• Act as validation liaison: Communicate with customers or regulatory agencies during facility audits.Key Qualifications
  • Bachelor's degree in Science, Engineering, or relevant field
  • Over 10 years of validation experience in the pharmaceutical industry
  • Must have strong experience in validation of equipment, facility and utility
  • Strong knowledge of FDA and EU regulations for pharmaceutical and validation requirements
    #J-18808-Ljbffr

Keywords: EPM Scientific - Phaidon International, Albuquerque , Senior Principal Validation Engineer, Engineering , Albuquerque, New Mexico