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Lead Validation Engineer

Katalyst Healthcares and Lifesciences

New Jersey • Today

Full-time

Validation Lead

HPTech Inc.

Hybrid in Raritan, New Jersey • Today

Easy Apply

Contract, Third Party

55 - 60

System Test and Validation Lead

Deloitte

Remote or Atlanta, Georgia • 2d ago

Full-time

USD 95,000.00 - 145,000.00 per year

Data Center Infrastructure Validation - Innovation Lead

EPRI

Remote or Washington, District of Columbia • Today

Full-time

USD 185,000.00 - 200,000.00 per year

Senior Device Validation Engineer

Flock Safety

Remote or Atlanta, Georgia • Today

Full-time

USD 150,000.00 - 190,000.00 per year

Staff Systems Engineer - Release Strategy & Validation

Torc Robotics

Remote or Ann Arbor, Michigan • Today

Full-time

USD 168,800.00 - 202,600.00 per year

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

Princeton, New Jersey • Today

Full-time

Senior Engineer, Process Validation

Danaher Corporation

Remote • Today

Full-time

USD 100,000.00 - 130,000.00 per year

Post-Silicon Systems Software Validation Engineer

Arrow Electronics, Inc.

Remote or California • Today

Full-time

USD 87,400.00 - 165,000.00 per year

Integration Validation Engineer- VHA Finance

HigherEchelon

Remote • Today

Full-time

Process Validation Engineer

Katalyst Healthcares and Lifesciences

Newark, New Jersey • Today

Full-time

Sr. AI Platform Development & Validation Engineer

AMD (Advanced Micro Devices)

Secaucus, New Jersey • Today

Full-time

USD 143,570.00 per year

Princiapl AI Validation and Test Engineer

AMD (Advanced Micro Devices)

Secaucus, New Jersey • Today

Full-time

USD 154,490.00 per year

Attack Surface and Exposure Validation Assistant Engineer

Hoboken, New Jersey • Today

Full-time

AI Systems Validation Engineer

AMD (Advanced Micro Devices)

Secaucus, New Jersey • Today

Full-time

USD 119,280.00 per year

AI Validation and Test Engineer

AMD (Advanced Micro Devices)

Secaucus, New Jersey • Today

Full-time

USD 119,280.00 per year

Data Validation Engineer

GlobalLogic Inc.

Remote • 19d ago

Easy Apply

Full-time

100000 - 110000

Engineer Pharma Validation

Medline Industries, LP

Remote • Today

Full-time

USD 73,000.00 - 110,000.00 per year

Lead QA Engineer

Randstad Digital

Jersey City, New Jersey • Today

Contract

USD55 - USD65

Lead QA Engineer

Inspiration Global

Berkeley Heights, New Jersey • Today

Easy Apply

Full-time, Part-time, Third Party, Contract

S/4 HANA VALIDATION

Resourcesys

Bridgewater, New Jersey • Today

Easy Apply

Contract

CSV Consultant(Computer System Validation ? GenAI, Agentic , SAP

W3Global

Raritan, New Jersey • Today

Contract

USD45.0/HOURLY - USD52.0/HOURLY

Lead Test Automation Engineer

Symetra Financial

Remote or Bellevue, Washington • Today

Full-time

USD 128,700.00 - 214,600.00 per year

Sr Generative AI Scientist II - (Model Risk & Validation)

Cotiviti

Remote • Today

Full-time

USD 145,000.00 - 170,000.00 per year

Generative AI Scientist - (Model Risk & Validation)

Cotiviti

Remote • Today

Full-time

USD 110,000.00 - 130,000.00 per year

Bioinformatics Pipeline Validation Manager with Cancer genomics exp (Remote -US)

OMG Technologies

Remote • Today

Easy Apply

Contract

Depends on Experience

Job Details

Skills

Functional Requirements
Project Planning
Regulatory Compliance
Communication
Life Sciences
PMP
Pharmaceutics
Biotechnology
GMP
IQ
OQ
PQ
Manufacturing
Cell Culture
Media
Chromatography
Good Manufacturing Practice
Quality Management
Auditing
Management
Budget
Documentation

Summary

Job Description:
The Lead Validation Engineer leads GMP equipment installation, commissioning, and qualification projects supporting large-molecule biologics manufacturing. This role supports upstream and downstream processes and ensures projects are executed safely, on schedule, and in compliance with regulatory and quality requirements.
Responsibilities:

Lead end-to-end CQV execution for GMP equipment projects, managing activities from installation through IQ, OQ, and PQ for biologics manufacturing systems including bioreactors, media/buffer preparation, chromatography, filtration, and associated utilities.
Drive project planning and execution, developing and maintaining integrated schedules, budgets, and resource plans while proactively identifying risks and implementing mitigation strategies to support on-time, compliant delivery.
Coordinate and direct cross-functional teams (Engineering, Manufacturing, MSAT, Quality, Validation, Automation, and vendors) to ensure alignment on technical requirements, execution strategy, and readiness for qualification milestones.
Ensure full regulatory and quality compliance, including adherence to cGMP, biosafety requirements, and site quality systems; review and approve URSs, FAT/SAT documentation, installation packages, and qualification protocols.
Serve as the primary technical and communication lead for equipment CQV activities, providing regular status updates to stakeholders and supporting change controls, deviations, and CAPAs related to equipment implementation and qualification.
Lead CQV activities for facility and utility upgrade projects, including AHU replacements, boiler replacements, generator improvements, clean steam generator replacements, RODI (reverse osmosis deionized) water skid upgrades, parts washer upgrades, and installation and qualification of autoclaves.

Requirements:

Bachelor's degree in Engineering, Life Sciences, or a related technical field; advanced degree or relevant certifications (e.g., CQV, PMP) preferred
7+ years of progressive experience in Commissioning, Qualification, and Validation (CQV) within GMP-regulated pharmaceutical or biotechnology manufacturing environments
Demonstrated experience leading GMP equipment and utility projects from installation through IQ, OQ, and PQ, supporting biologics manufacturing processes such as CHO cell culture, media/buffer preparation, chromatography, filtration, and clean utilities
Strong working knowledge of cGMP regulations, biosafety requirements, and site quality systems, with experience supporting regulatory inspections and audit readiness
Proven ability to lead cross-functional teams and vendor partners, manage project schedules and budgets, and communicate technical status, risks, and mitigation plans to stakeholders
Hands-on experience reviewing and approving URSs, FAT/SAT documentation, installation packages, qualification protocols, and supporting change controls, deviations, and CAPAs
Preferred experience supporting facility and utility upgrade projects, including AHU replacements, boiler replacements, generator improvements, clean steam generator replacements, RODI water skid upgrades, parts washer upgrades, and installation/qualification of autoclaves

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: e5db1354bbbf7aa207c90e9a54712cd9
Posted 30+ days ago

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Senior Validation Engineer

Rock Hill, South Carolina

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Job Description: Senior Validation Engineer with experience supporting commissioning, qualification, and validation activities for process equipment in GMP-regulated environments. Responsible for executing IQ/OQ protocols, equipment verification, temperature mapping, SIP/CIP validation activities, deviation support, and ensuring compliance with GMP/GDP standards while collaborating with Engineering, QA, and Operations teams. Roles & Responsibilities: Execute Installation Qualification (IQ) and

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Senior Validation Engineer

Evansville, Indiana

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Senior Validation Engineer Consultant

Massachusetts

•

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Job Description: Senior CQV Engineer / Senior Validation Engineer with experience supporting commissioning, qualification, and validation activities for process equipment in GMP-regulated environments. Responsible for executing IQ/OQ protocols, equipment verification, temperature mapping, SIP/CIP validation activities, deviation support, and ensuring compliance with GMP/GDP standards while collaborating with Engineering, QA, and Operations teams. Roles & Responsibilities: Execute Installation Q

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Validation Engineer

Chelsea, Massachusetts

•

Today

Validation Engineer Position Summary: Work Schedule: Monday - Friday, 8:00am to 5:00pm100% on-site The Chelsea facility is Catalent's global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest Good Manufacturi

Full-time

USD 89,000.00 - 110,000.00 per year

Job Details

Skills

Functional Requirements
Project Planning
Regulatory Compliance
Communication
Life Sciences
PMP
Pharmaceutics
Biotechnology
GMP
IQ
OQ
PQ
Manufacturing
Cell Culture
Media
Chromatography
Good Manufacturing Practice
Quality Management
Auditing
Management
Budget
Documentation

Summary

Lead end-to-end CQV execution for GMP equipment projects, managing activities from installation through IQ, OQ, and PQ for biologics manufacturing systems including bioreactors, media/buffer preparation, chromatography, filtration, and associated utilities.
Drive project planning and execution, developing and maintaining integrated schedules, budgets, and resource plans while proactively identifying risks and implementing mitigation strategies to support on-time, compliant delivery.
Coordinate and direct cross-functional teams (Engineering, Manufacturing, MSAT, Quality, Validation, Automation, and vendors) to ensure alignment on technical requirements, execution strategy, and readiness for qualification milestones.
Ensure full regulatory and quality compliance, including adherence to cGMP, biosafety requirements, and site quality systems; review and approve URSs, FAT/SAT documentation, installation packages, and qualification protocols.
Serve as the primary technical and communication lead for equipment CQV activities, providing regular status updates to stakeholders and supporting change controls, deviations, and CAPAs related to equipment implementation and qualification.
Lead CQV activities for facility and utility upgrade projects, including AHU replacements, boiler replacements, generator improvements, clean steam generator replacements, RODI (reverse osmosis deionized) water skid upgrades, parts washer upgrades, and installation and qualification of autoclaves.

Requirements:

Bachelor's degree in Engineering, Life Sciences, or a related technical field; advanced degree or relevant certifications (e.g., CQV, PMP) preferred
7+ years of progressive experience in Commissioning, Qualification, and Validation (CQV) within GMP-regulated pharmaceutical or biotechnology manufacturing environments
Demonstrated experience leading GMP equipment and utility projects from installation through IQ, OQ, and PQ, supporting biologics manufacturing processes such as CHO cell culture, media/buffer preparation, chromatography, filtration, and clean utilities
Strong working knowledge of cGMP regulations, biosafety requirements, and site quality systems, with experience supporting regulatory inspections and audit readiness
Proven ability to lead cross-functional teams and vendor partners, manage project schedules and budgets, and communicate technical status, risks, and mitigation plans to stakeholders
Hands-on experience reviewing and approving URSs, FAT/SAT documentation, installation packages, qualification protocols, and supporting change controls, deviations, and CAPAs
Preferred experience supporting facility and utility upgrade projects, including AHU replacements, boiler replacements, generator improvements, clean steam generator replacements, RODI water skid upgrades, parts washer upgrades, and installation/qualification of autoclaves

Dice Id: 91116760
Position Id: e5db1354bbbf7aa207c90e9a54712cd9
Posted 30+ days ago

Fitment

Dice Job Match Score™

📋 Comparing job requirements...

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Senior Validation Engineer

Rock Hill, South Carolina

•

Today

Full-time

Senior Validation Engineer

Evansville, Indiana

•

Today

Full-time

Senior Validation Engineer Consultant

Massachusetts

•

Today

Full-time

Validation Engineer

Chelsea, Massachusetts

•

Today

Full-time

USD 89,000.00 - 110,000.00 per year