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 re-validations.
- 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. Advanced degree is preferred.
- 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
- Must have experience working in an aseptic/sterile manufacturing facility with strong understanding of the sterile manufacturing process.
- Experience supporting or leading an expansion project is highly preferred.
