We are partnered with an amazing organization in New Mexico. They are a well-established CDMO who are looking to hire a Senior Validation Engineer. You will be responsible for developing and executing validation plans for equipment, processes, and systems to ensure compliance with regulatory standards as well as create and review validation protocols, oversee testing activities, and analyze data to confirm that operations meet quality and safety requirements.
DUTIES AND RESPONSIBILITIES:
- Develop and implement validation and revalidation protocols for processes, equipment, utilities, and testing systems.
- Create and document Standard Operating Procedures (SOPs) for new processes and equipment.
- Assist with departmental projects by supporting engineers in calibration and validation efforts.
- Contribute to internal and external audits by providing and presenting relevant data as needed.
- Keep department management and staff informed about validation issues that could affect regulatory compliance or financial outcomes.
- Ensure that change controls, records, and procedures adhere to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
- Review and draft validation protocols, final reports, and summaries for equipment release.
- Assist in reviewing validation protocols for computer systems, environmental monitoring, process validations, and cleaning validations.
- Participate in the assessment of changes made under the Change Control System from a validation standpoint.
- Provide validation oversight for facility, utility, and equipment upgrades.
- Offer validation insights during technology transfers.
- Read and interpret SOPs to ensure compliance.
- Maintain up-to-date training records.
- Perform other duties as assigned.
Education and Experience:
- Bachelor’s degree
- Eight (8) years of relevant experience in pharmaceutical validation, in an aseptic or sterile product facility.
- Familiarity with FDA and EU regulations pertaining to pharmaceuticals and validation requirements is preferred.
- Experience with validation tools and processes is preferred.
