Validation Engineer

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This range is provided by Redbock - an NES Fircroft company. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$40.00/hr - $50.00/hr

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)
• 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.

Qualifications /

Skills:

• 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.

Seniority level:
Mid‑Senior level

Employment type:

Contract

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