Validation Engineer

Recruitment Consultant II at Redbock - an NES Fircroft company

A fast-growing biotechnology company is expanding their team in Salt Lake City, and they are in immediate need of a Validation Engineer to support them fully onsite for 12 months
. The 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.

This role is focused on process validation, and this consultant will be the first person on the SLC team focused on process validation supporting the MSAT team. They are currently a clinical manufacturing site but need to get ready for PPQ runs and eventually commercial manufacturing of the first product. This consultant should have prior experience working on single‑use biologics manufacturing through PPQ.

• 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).
• Provide training and technical guidance to operations and cross‑functional partners during validation activities.
• Work intermittent, on‑call schedules as needed to support process validation activities.

• Bachelor’s or higher in Chemical, Mechanical, Biomedical, or related Engineering discipline.
• 3‑10 years of experience in biopharma process or validation engineering,
  preferably within GMP biologics manufacturing
  .
• Hands‑on experience with process validation.
• Equipment validation experience is a bonus but not required.
• 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. Client is moving to PAS‑X.
• Strong communication, teamwork and technical writing abilities.
• Ability to thrive in a fast paced, collaborative environment.
• Ability to don specialized gowning and work in classified cleanroom environments.
• Lift and manipulate items over 25 lbs, climb ladders, stand for extended periods.

Associate

Contract

Consulting and Engineering

Biotechnology Research and Pharmaceutical Manufacturing

• Medical insurance
• Vision insurance
• 401(k)
• Disability insurance

• Base pay range: $50.00 /hr - $65.00 /hr