Sr. Process Validation Engineer

Position: Sr. Process Validation Engineer Location: Salt Lake City, UT (Onsite)

Experience: 5+ Years Duration: 12+ Months

Overview

The Senior Validation Engineer will play a central role in supporting process validation and equipment qualification activities within a GMP biologics manufacturing environment. This position focuses on developing and executing validation strategies, ensuring alignment with regulatory expectations, and driving cross-functional coordination to maintain a compliant and efficient operation.

Key Responsibilities

• Develop, execute, and document validation strategies aligned with FDA, EMA, and ICH Q7–Q10 guidance.

• Lead or support Process Validation Studies and PPQ activities, including protocol drafting, approval, and execution.

• Perform commissioning and qualification (C&Q) for GMP equipment, utilities, and facility systems, including protocol authoring and execution.

• Conduct risk and gap assessments for manufacturing processes and equipment, recommending appropriate validation strategies.

• Perform periodic equipment lifecycle reviews to ensure systems remain qualified, controlled, and compliant.

• Maintain accurate equipment master data, including technical specifications and operational details for audit readiness.

• Manage change control processes with thorough assessment and consistent documentation.

• Collaborate with Manufacturing, QA, QC, and Process Development teams to support seamless validation execution.

• Draft, revise, and maintain SOPs, protocols, and reports to reflect accurate process conditions and regulatory expectations.

• Ensure alignment between process requirements, equipment qualifications, and control strategies throughout validation activities.

• Execute validation studies on the manufacturing floor, coordinating equipment setup, monitoring, sampling, and data collection in GMP cleanrooms.

• Coordinate and perform sampling activities using proper aseptic techniques, ensuring correct labeling, chain of custody, and timely transfer to QC or analytical labs.

• Process and prepare samples for analysis, including incubation, filtration, aliquoting, and stabilization, while maintaining strict data integrity standards.

• Support recipe authoring, data trending, and control strategy development for batch records and process automation systems.

• Provide training and technical guidance to operations and cross-functional teams during validation initiatives.

• Support intermittent or on-call schedules as needed to meet validation demands.

Qualifications & Skills

• • Bachelor’s degree or higher in Chemical, Mechanical, Biomedical, or related Engineering field.

• • Minimum 5+ years of experience in biopharma process or validation engineering, preferably within GMP biologics manufacturing.

• • Strong experience with process validation and equipment qualification.

• • Familiarity with FMEA, risk-based validation methods, and documentation systems.

• • Knowledge of FDA/EMA cGMP regulations and ICH Q7–Q10 guidance.

• • Experience with MES, process automation platforms, and LIMS tools.

• • Hands-on laboratory skills: pipetting, aliquoting, labeling, and material handling.

• • Strong communication skills, teamwork mindset, and technical writing capability.

• • Ability to excel in a fast-paced, collaborative environment.

• • Ability to gown and work within classified cleanroom environments.