What are the responsibilities and job description for the Senior Principal Validation Engineer position at EPM Scientific?
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
