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Validation engineer Jobs in Durham, NC

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Validation engineer • durham nc

Last updated: 4 days 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

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

 • Promoted

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

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

Mechanical Engineer

LancesoftDurham, NC, US
Full-time
Quick Apply

Developing root cause analysis techniques.O Familiar with standards and regulations (ISO, FDA, OSHA, ASTM).O Can operate and troubleshoot mechanical test equipment in the lab.O Developing in the op... 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

Solutions Engineer

Keebler HealthDurham, North Carolina, United States, 27705
Full-time
Quick Apply

Keebler Health is building the operating system for value-based care.Our mission is to help risk-bearing healthcare organizations thrive in value-based arrangements by unlocking the full power of t... Show more

Process Engineer – Pharmaceutical (Process Validation, PPQ, cGMP)

Stark Pharma Solutions IncDurham, NC, United States
Full-time
Quick Apply

ABOUT COMPANY:</b></p> <p dir="ltr">Stark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting pharmaceutical, biotechnology and medical devic... 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

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

AI Engineer III

Victra - Verizon Wireless Premium RetailerDURHAM, NC, US
Full-time

Victra is Verizon’s largest premium retailer in the United States.We thrive on collaboration, innovation, and performance.Our mission is to “Connect technology to life in a trustworthy, fun, and pr... 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 empl... Show more

Hotel Engineer

Millennium Hotels and ResortsDurham, NC, US
Full-time
Quick Apply

Millennium Hotel Durham .Onsite – Durham, NC .Join the Team at Millennium Durham.Every interaction is an opportunity to create comfort, connection, and a l... Show more

Transportation Engineer

Trilon GroupDurham, North Carolina, US
$90,000.00–$111,000.00 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

Systems Engineer

Patriot, LLCResearch Triangle Park, NC, US
Full-time
Quick Apply

The Systems Engineer will participate and perform in a variety of activities including proactive solution development; collaboration with other Engineers and support teams for problem resolution; a... 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.