Redbock - an NES Fircroft company · 10 hours ago
Validation Engineer
SLC Metro Area
Contract
Onsite
Mid, Senior Level
$40/hr - $50/hr
3+ years expRedbock, an NES Fircroft company, is seeking a Validation Engineer to develop and execute validation strategies compliant with FDA and EMA regulations. The role involves leading process validation studies, conducting risk assessments, and collaborating with various teams to ensure successful validation activities.
BiotechnologyConsultingMedical DevicePharmaceutical
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
Qualification
Required
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
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
Preferred
Equipment validation experience is a bonus but not required
Company
Redbock - an NES Fircroft company
Redbock is a consultancy that delivers customized resourcing solutions to pharmaceutical, biotechnology, medical device and diagnostics companies.
51-200 employees
H1B Sponsorship
Redbock - an NES Fircroft company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (5)
2023 (1)
2022 (1)
2021 (8)
2020 (9)
Funding
Current Stage
Growth StageTotal Funding
unknown2018-06-20Acquired
Company data provided by crunchbase