Senior Validation Engineer

A fast-growing biotechnology company is expanding their team in Salt Lake City, and they are in immediate need of a Sr. Validation Engineer to support them fully onsite for 12 months. The Sr. Validation Engineer will serve as a key contributor to process validation and equipment qualification initiatives, supporting GMP biologics manufacturing. This position is responsible for developing and executing validation strategies, authoring protocols, coordinating cross-functional activities and ensuring regulatory compliance.

Key Accountabilities/ Core Job Responsibilities:

• Develop, execute and document validation strategies that comply with FDA, EMA and ICH Q7 – Q10 guidance.
• Lead or support Process Validation Studies and Process Performance Qualification (PPQ) protocol drafting, approval and execution, ensuring alignment with site or corporate validation plans.
• Perform commissioning and qualification (C&Q) for GMP equipment, utilities, and facility systems, including authoring protocols and reports and executing studies in compliance with SOPs, validation plans, and regulatory requirements and expectations.
• Conduct risk and gap assessments on manufacturing processes and equipment, recommending strategies for process and equipment validation execution.
• Conduct periodic reviews as part of equipment lifecycle management to ensure systems remain qualified, controlled, and compliant.
• Maintain accurate equipment master data, updating technical specifications and operational details for compliance and audit readiness.
• Manage change control procedures to ensure thorough evaluation and consistent documentation.
• Collaborate with Manufacturing, QA, QC and PD teams to ensure seamless execution and documentation of validation activities.
• Draft, revise and maintain SOPs, protocols and reports that accurately reflect process conditions, equipment configurations and regulatory compliance.
• Maintain alignment between process requirements, equipment qualifications and control strategies throughout the validation lifecycle.
• Execute validation studies on the manufacturing floor in collaboration with operations, coordinating equipment setup, process monitoring, sampling, and in-process data collection within GMP cleanroom environments.
• Coordinate and perform sampling activities, ensuring appropriate aseptic technique, chain of custody, labeling and timely transfer to QC or analytical laboratories.
• Process and prepare samples for analysis (e.g., incubation, filtration, aliquoting, stabilization) while maintaining full compliance with data integrity and documentation standards.
• Support recipe authoring, data trending and control strategy development for manufacturing systems (batch records, process automation)

Qualifications/Skills:

• Bachelor’s or higher in Chemical, Mechanical, Biomedical, or related Engineering discipline.
• Minimum 5 years in biopharma process or validation engineering, preferably within GMP biologics manufacturing.
• Hands-on experience with process validation and equipment qualification.
• Familiarity with FMEA, risk-based validation and documentation systems.
• Knowledge of FDA/EMA cGMP and ICH Q7 – Q10 regulations
• Experience using MES, process automation and LIMs tools.
• Hands-on experience performing routine laboratory tasks; pipetting, aliquoting, sample labeling, and material handling.