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Validation engineer Jobs in Durham, NC

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Validation engineer • durham nc

Last updated: 1 day ago

Validation Project Lead / Documentation Audit Lead

FSTDurham, NC, United States
Full-time

Validation Project Lead / Documentation Audit Lead.FST Technical Services is seeking an experienced Validation Project Lead / Documentation Audit Lead to support a large pharmaceutical manufacturin... Show more

Senior Network Engineer

Delan Associates, IncDurham, United States
Full-time

Must have ansible and terraform experience.Senior L3 Network Engineer (Cisco, Palo Alto, SD-WAN, Cloud & OT).Provide L3 support for enterprise, data center, cloud, and manufacturing network env... Show more

Remote Mechanical Engineer

Micro1Cambridge, Maryland, US
Remote
Full-time

AI data lab for training frontier models and evaluating AI agents.Experts contribute their diverse subject matter knowledge across domains such as finance, healthcare, STEM engineering, and more.AI... Show more

Senior Electrical Engineer

Ardurra Group, Inc.Durham, US
Full-time

RVE (an Ardurra company) is seeking a Senior Electrical Engineer to join our team in Durham, NC.Our professionals combine engineering expertise with sound economic and management principles to desi... Show more

Service Sales Engineer

GpacDurham, North Carolina, United States
Full-time

This is a great opportunity for someone with.Manage bid opportunities from initial review through proposal, including takeoffs, RFIs, scopes, and estimating.Review plans, specifications, equipment ... Show more

Insurance Systems Quality Engineer

Piper CompaniesDurham, North Carolina
$125,000.00 yearly
Full-time

Piper Companies is seeking an Insurance Systems Quality Engineer to join a leading insurance and financial services organization.The Insurance Systems Quality Engineer will support testing efforts ... Show more

Packaging Project Engineer

CorningDurham, NC, US
Full-time

The company built on breakthroughs.Corning is one of the world’s leading innovators in glass, ceramic, and materials science.From the depths of the ocean to the farthest reaches of space, our techn... Show more

Splunk / SOC Engineer

Zachary PiperRTP, North Carolina
Full-time

Splunk Engineer / SOC Engineer.This role plays a critical part in enhancing detection capabilities, improving security visibility, and driving operational efficiency through Splunk engineering and ... Show more

Linguistic Validation & eCOA Project Manager

Avery Healthcare Group Ltd.Durham, NC, United States
$59,800.00–$149,500.00 yearly
Part-time

Manages the operational aspects of projects and programs.Ensures that all project work is completed in accordance with SOPs, policies and practices.Create, track and report on project timelines.Man... Show more

Sr/Principal Computer Systems Validation Specialist

KBI BiopharmaDurham, NC, United States
$118,000.00–$162,800.00 yearly
Full-time

IT Validation & Compliance Manager.This individual will provide thought-leadership, expertise, and management of managed validation services to the IT Validation & Compliance infrastructure in a Co... Show more

Automation Engineer

Amazon.com Services LLC - A57Durham, North Carolina, USA
Full-time

Operations is at the heart of Amazon’s business.We are known for our speed, accuracy, and exceptional service.Our buildings deliver tens of thousands of products to hundreds of countries worldwide,... Show more

Customer Success Engineer

3EDurham, NC, US
Full-time
Quick Apply

As a Customer Success Engineer, you'll play a pivotal role in managing the end-to-end customer journey: from onboarding new clients through to driving the ongoing success of mature accoun... Show more

Director, Software Engineer

NetAppDurham, NC, United States
Full-time

Director of Software Engineering.The Director of Software Engineering leads multiple software engineering teams responsible for the delivery of innovative, scalable, secure, and reliable products a... Show more

Product Marketing Engineer

Analog DevicesDurham, NC, United States
$157,080.00–$227,460.00 yearly
Full-time

NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge.ADI combines analog, digital, and software technologies in... Show more

Chief Engineer

Island Hospitality ManagementDurham, NC, United States
Full-time

We are currently seeking a Chief Engineer for our hotel that enjoys resolving problems, working with their hands, and general building maintenance.This position may require flexible scheduling avai... Show more

Remote Mechanical Engineer

Micro1Durham, North Carolina, US
Remote
Full-time

AI data lab for training frontier models and evaluating AI agents.Experts contribute their diverse subject matter knowledge across domains such as finance, healthcare, STEM engineering, and more.AI... Show more

Validation Area Specialist I/II - SDF

Novo NordiskDurham, NC, US
Full-time

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity.Being part of Novo Nordisk allows our ... Show more

Principal Software Engineer

LCA Lab. Corp. of AmericaDurham NC
Full-time

Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confide... Show more

Sales Engineer – Automation

HiringArcResearch Triangle Park, NC, USA
$90,000.00 yearly
Full-time

Sales Engineer– Industrial and Automation.Join a global leader in power and thermal management solutions, celebrated for innovative approaches and advanced technologies.With a steadfast commitment ... Show more

Product Development Engineer

Intuitive SurgicalDurham, NC, United States
$114,800.00–$155,300.00 yearly
Full-time

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at.We’re a team of engineers, clin... Show more

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The cities near Durham, NC that boast the highest number of validation engineer jobs are:
Validation Project Lead / Documentation Audit Lead

Validation Project Lead / Documentation Audit Lead

FSTDurham, NC, United States
30+ days ago
Job type
  • Full-time
Job description

Validation Project Lead / Documentation Audit Lead

FST Technical Services is seeking an experienced Validation Project Lead / Documentation Audit Lead to support a large pharmaceutical manufacturing facility construction project. This role is responsible for establishing a standardized process for the validation of hygienic welding documentation (Isometrics) to ensure compliance with project specifications, applicable codes (e.g., ASME BPE), and industry best practices to support full traceability for hygienic systems.

Responsibilities:

  • Lead documentation audit activities to ensure full traceability of hygienic piping systems.
  • Manage schedule, priorities, milestones, and deliverables.
  • Audit weld documentation packages for GMP and Good Documentation Practices (GDP) compliance.
  • Ensure document traceability.
  • Coordinate resolution of documentation deficiencies and quality observations.
  • Partner with Construction Management, Fabricators and Client representatives.
  • Maintain validation metrics and documentation status reports.
  • Mentor junior validation specialists and documentation specialists.

Required Qualifications:

  • Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related technical discipline (or equivalent experience).
  • 8+ years of pharmaceutical validation, CQV, QA, or GMP documentation experience.
  • 3+ years leading validation documentation or CQV teams on large pharmaceutical capital projects.
  • Strong knowledge of FDA cGMP regulations (21 CFR Parts 210 & 211).
  • Thorough understanding of Good Documentation Practices (GDP).
  • Experience supporting Commissioning, Qualification & Validation activities.
  • Experience preparing projects for client and regulatory audits.
  • Excellent project management, organization, and communication skills.

Preferred Qualifications:

  • Experience with Traceability Matrices, ALCOA+, Equipment & Utilities Installation Qualification,

Experience with EIDA, Bluebeam, Microsoft Office and SharePoint.