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Validation engineer Jobs in Durham, NC

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Validation engineer • durham nc

Last updated: 17 hours 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

Software Engineer

Teledyne Technologies IncorporatedNC,Durham,US
Full-time

Teledyne Scientific Company (TSC) has a legacy of over 60 years of advanced research and technology development.Our customer base consists of DARPA, ONR, AFRL, ARL, and other government and proprie... 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

Cleaning Validation Engineer

MedPharmDurham, NC, US
Full-time
Quick Apply

Position Summary – The Cleaning Validation Engineer oversees the development, maintenance, and governance of MedPharm’s site-wide cleaning validation program across the full product lif... Show more

Validation Project Lead / Documentation Audit Lead

FST Technical ServicesDurham, NC, US
Full-time
Quick Apply

Validation Project Lead / Documentation Audit Lead Major Pharmaceutical Facility Construction Project Location:.Durham, NC - FST Life Science office FST Technical Services is seeking an experienced... 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

Operating Engineer

JLLDurham, NC, United States
Full-time

Specialist, Engineering Services JLL.Our people at JLL are shaping the future of real estate for a better world by combining world class services, advisory and technology for our clients.We are co... Show more

 • New!

Process Validation Engineer3

LancesoftDurham, NC, US
Full-time
Quick Apply

Operational Excellence Engineer.On site, 5 days at week, Industrial Engineer.This position is responsible for implementing and sustaining the Operational Excellence strategy through the achievement... Show more

Project Engineer

Veteran Hiring SolutionsDurham, NC, us
Full-time

Project Manager, with functional direction from the Engineering leader (Tim).Small, tightly integrated facility team where operations, plant engineering, project engineering, and automation work as... Show more

Associate Software Engineer

Red Hat, LLCDurham
$94,182.00 yearly
Full-time

Telecommuting permitted: work may be performed within normal commuting distance from the Red Hat, LLC office in Durham, NC.Design and develop server-side logic and modular software components for e... Show more

Sr/Principal Computer Systems Validation Specialist

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

This individual will provide thought-leadership, expertise, and management of managed validation services to the IT Validation & Compliance infrastructure in a Contract Development and Manufacturin... 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

Engineer3, Process Validation

Kaygen Inc.Durham, NC, US
Permanent +1

KAYGEN is an emerging leader in providing top talent for technology-based staffing services.We specialize in providing high-volume contingent staffing, direct hire staffing and project-based soluti... Show more

 • Promoted

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

Engineer3, Process Validation

MillenniumSoft IncDurham, NC, United States
Full-time
Quick Apply

Operational Excellence Engineer.On site, 5 days at week, Industrial Engineer<br><br></b></p> Position Summary <p>This position is responsible for implementing and sust... 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

Sr Lead Systems Engineer / AWS Cloud Engineer

LCH Lab. Corp. of America HoldingsDurham NC
Full-time

Labcorp is seeking a Senior AWS Cloud Engineer to join our team at our Durham, NC!.Applicants who live within 35 miles of Durham, NC location will follow a hybrid schedule.This schedule includes a ... 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

Transportation Engineer

Trilon GroupDurham, North Carolina, US
$90,000.00 yearly
Full-time
Quick Apply

Active Transportation Engineer.This mid-career role is a fantastic opportunity for someone passionate about sustainable transportation in bike and pedestrian infrastructure and eager to advance the... 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
8 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.