Engineer, Validation

Position Summary

The Engineer, Validation provides validation support to Immunotherapy Production, Quality Control and Plant Engineering. This role also provides activity updates to Validation Manager on a regular basis to ensure compliance issues are being met.

Essential Functions and Responsibilities

• Develop, review, and approved technical documents such as qualification protocols (IQ/OQ/PQ), final reports, change controls, SOPs, deviations, etc.
• Manager, schedule, coordinate, and execute assigned qualification or validation activities to ensure timely completion of the validation plan in coordination with the system owner. These qualification/validation activities include facilities, utilities, equipment, and computer systems.
• Support the validation strategy used at ADMA Biologics ensuring it is harmonized with regulatory standards and current good manufacturing practices.
• Support maintaining all process and laboratory equipment, facilities, and critical systems/utilities in a qualified/validated state.
• Assist in the investigation of deviations encountered during the execution of validation protocols and provide documentation to support such an effort.
• Reviews executed protocols for completeness, cGxP compliance, data acceptability, and data integrity.
• Supports the site periodic reviews and requalification programs.
• Works with other departments to troubleshoot equipment.
• Interact with FDA investigators regarding validation compliance issues and regulatory requirements.
• Coordinate and support validation activities with appropriate departments and contract validation firm employees.
• Monitor validation activities or contract employees assigned to validation projects.

Requirements

• Bachelor's degree in science or engineering.
• 3+ years validation experience in a cGMP, Pharmaceutical/Biological manufacturing environment.

Compliance Requirements

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Benefits

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company paid STD and LTD
• Company Paid Holidays
• 3 Weeks' Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri-Rail. Free shuttle to the Boca Tri-Rail station