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Staff Software Engineer
Natera
Remote, United States
Natera is seeking a Staff Software Engineer to join a small, high-leverage team inside the Case Management Platform (CMP) organization. This is a new and intentionally unique role: you will…
Added 1 min ago
Façade Engineering-Structural- 3 to 8 Years Experience
KPFF Consulting Engineers
Portland, OR
As a Structural Engineer specializing in façade design, you will contribute both individually and collaboratively throughout the design and construction process across a wide range of…
Added 1 min ago
Azure DevOps Engineer – Release Coordinator
Sentinel
Remote, United States
We seek a detail-oriented and highly collaborative Azure DevOps Engineer – Release Coordinator to join our client’s Software Development team. This role is pivotal in managing CI/CD…
Added 1 min ago
IBM Maximo Senior Business Analyst
NiyamIT
Remote, United States
Niyam was founded in 2007 by a group of consultants who shared a unique vision: a technology company steeped in orderly process yet driven by passion and innovation. For nearly two decades,…
Added 1 min ago
SO
Fabrication Engineer – Scorpius (ASD)
Salas O'Brien
Los Alamos, NM
- $90,000 to $150,000 USD / year
Identify and document nonconforming materials; initiate, process, and coordinate nonconformance reports (NCRs) through resolution.
Added 2 mins ago
IT Storage Engineer
SpaceX
Memphis, TN
SpaceX is seeking an experienced storage engineer with deep expertise in enterprise storage platforms. This role is ideal for someone who thrives in performance-critical settings and is…
Added 2 mins ago
Machine Learning Engineer
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Sunnyvale, CA
The Machine Learning Engineer will join the Customer Systems team to design, develop, and optimize production-grade AI solutions, with a focus on Large Language Models (LLMs), agentic AI…
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Knowledge Based Engineering (KBE) Engineer - Closures / BIW
Stellantis
Auburn Hills, MI
The KBE Advance Body / closures Development Engineer will be responsible for the rapid development of component template models that incorporate engineering requirements, best practices…
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PMO APQP Quality Specialist
Stellantis
Auburn Hills, MI
The Engineer's responsibilities include but are not limited to: performing root cause analysis of quality issues, often using advanced problem-solving tools (Kepner-Tregoe, Shainin Red X,…
Added 3 mins ago
PMO Quality Specialist
Stellantis
Auburn Hills, MI
The Engineer's responsibilities include but are not limited to: performing root cause analysis of quality issues, often using advanced problem-solving tools (Kepner-Tregoe, Shainin Red X,…
Added 3 mins ago
Operational Excellence Manager
Quest Defense Systems & Solutions, Inc.
Remote, United States
…the enterprise leader for Quality, AS9100 compliance, LEAN process improvement, and cross‑functional workflow optimization. This role ensures that QDSS operates with disciplined, scalable,…
Added 4 mins ago
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Engineer Manager
natgridProd
Hicksville, NY
- $162,000 to $193,000 USD / year
Added 4 mins ago
Windows Systems Engineer
Samsung SDS America
Plano, TX
We are seeking a Senior Microsoft Exchange and Active Directory Engineer to design, implement, maintain, and optimize enterprise messaging and directory services to ensure secure, highly…
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Staff Data Engineer - Databricks
CVS Health
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We are seeking a highly experienced and technically proficient Staff Data Engineer to join our team. This is a senior individual contributor role for a leader who is passionate about…
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Robotics HW Engineer
Multiply Labs
United States
- $11,000 to $180,000 USD / year
As a Robotics HW Engineer in the Multiply Labs team, you will apply your engineering expertise and hands-on technical skills to design complex automated machinery involved in the…
Added 5 mins ago
Software Engineer V
Indeed
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As a Software Engineer V at Indeed, you will provide technical leadership on complex, cross-cutting platforms and systems that enable teams across the company to build high-impact products…
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AI Engineer ||
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The AI Engineer is responsible for designing and delivering AI-powered solutions that improve engineering productivity and business workflows. This role requires a strong foundation in…
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Mechanical Engineer
Cantrell - Gainco
Gainesville, GA
The Mechanical Engineer - Sustaining supports Cantrell-Gainco equipment throughout its life through engineer-to-order (ETO) processing, product life-cycle management, and continuous…
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Commissioning Field Engineer - Mechanical
Hoffman Construction Company
Boise, ID · ID · Hauser, ID · Kuna, ID · Moscow, ID · Post Falls, ID · Lewiston Orchards, ID
Position Summary: The Field Commissioning Engineer - Mechanical, will lead our commissioning team and information from start to finish for large semiconductor projects. The Field…
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Plant Reliability Engineer
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- $80,000 to $100,000 USD / year
We're looking for a Plant Reliability Engineer to help maximize equipment performance, improve maintenance processes, and support efficient manufacturing operations.
Added 6 mins ago
Lead Hardware Engineer
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Drive products through NPI - lead initial builds, own clear to build, drive procedure and process generation, define V+V metrics
Added 6 mins ago
Staff Engineer, Product Software
Equinix (US) Enterprises, Inc.
United States
The Staff Engineer for the daVinci - Network Observability team is the lead technical authority for the design and implementation of Equinix’s global telemetry fabric. You bridge the gap…
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Principal Product Manager, Agent Intelligence
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A systems engineering background: several years building or operating distributed systems, data platforms, infrastructure or ML systems as an engineer, or equivalent hands-on depth
Added 7 mins ago
Senior II Analyst/Engineer
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Quickly understanding current business processes, then determining and implementing process improvements that align with system development
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Quality Control Inspector (Fabrication & Assembly)
United States
The QC Inspector reports to the QC Manager and works in coordination with the Quality Engineer to ensure defects are identified and contained as early as possible in the production process.

Actalent

Validation Engineer

Raleigh, NC, United States

$60 to $66 USD / hour

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Job details

Pay: $60 to $66 USD / hour
Experience: 35 years of experience in a position of similar scope and responsibility.
Posting language: English
Posted: Nov 4, 2026

Original job description

Job Title: Validation EngineerJob DescriptionThis hybrid Validation Engineer role focuses on implementing and validating GxP computerized systems within an R&D IT environment. You will apply Computer Software Assurance (CSA) and Computer System Validation (CSV) principles to SaaS applications and AI models, ensuring compliance with US and EU regulations. The position emphasizes technical writing, validation strategy, and hands-on system implementation, particularly in support of regulatory processes such as electronic Instructions for Use, electronic Prescribing Information, Regulatory Intelligence, and Regulatory Submission and Deficiency management.

Responsibilities

Develop and execute validation strategies for GxP computerized systems in alignment with GAMP 5 principles, US Code of Federal Regulations, and EU Annex 11 regulations.
Apply computer software assurance (CSA) principles to ensure risk-based, compliant implementation of computerized systems.
Review existing processes and procedures and implement GxP computerized software in a compliant, efficient, and sustainable manner.
Lead and facilitate cross-functional meetings with stakeholders, ensuring clear communication, alignment, and timely decision-making.
Build and maintain strong working relationships with R&D IT, Regulatory, Quality, and other relevant teams to support successful system implementation.
Author comprehensive validation documentation, including validation plans, user requirements, test plans, test scripts, and summary reports to support software implementation.
Prepare and manage change controls and related documentation to ensure controlled implementation and updates of validated systems.
Develop and maintain training documentation, including User and Admin Standard Operating Procedures (SOPs), work instructions, and user guides.
Utilize electronic validation applications to manage and document validation activities, where applicable.
Plan and manage the implementation of GxP computerized systems, including project setup, configuration activities, and coordination with technical and business stakeholders.
Lead and coordinate user acceptance testing (UAT), including test planning, execution oversight, defect tracking, and resolution.
Provide hypercare support after go-live to monitor system performance, resolve issues, and ensure a smooth transition to steady-state operations.
Drive user adoption of new applications through structured training, communication, and change management activities.
Maintain the validated state of applications by ensuring ongoing compliance with policies, procedures, and regulatory expectations.
Support the development and maintenance of standard operating procedures, validation deliverables, and training materials related to GxP systems.
Run projects and strategic initiatives related to computer system validation, CSA, and regulatory technology solutions.
Collaborate with Regulatory Affairs and related functions on systems that support Regulatory Submissions, Regulatory Intelligence, and deficiency management.
Contribute to continuous improvement initiatives by identifying opportunities to streamline validation processes and enhance documentation quality.
Perform general office tasks such as sitting, standing, and using standard office equipment, and occasionally handle light physical activities related to the role.

Essential Skills

Proven experience with Computer System Validation (CSV), Computer Software Assurance (CSA), and GxP-relevant applications.
Strong subject matter expertise with GAMP 5 principles, US Code of Federal Regulations, and EU Annex 11 regulations.
Demonstrated ability to apply CSA principles to the validation of computerized systems in a regulated environment.
Ability to review and interpret processes and procedures and implement GxP computerized software in a compliant manner.
Proficiency in authoring validation documents, including validation plans, user requirements, test protocols, test reports, and change controls.
Experience writing standard operating procedures (SOPs), validation deliverables, and training materials for technical and business audiences.
Capability to develop training documentation and User and Admin SOPs that clearly explain system use and controls.
Experience running projects and strategy initiatives related to validation, regulatory systems, or R&D IT solutions.
Bachelors degree in Computer Science, Information Systems, or a related discipline.
35 years of experience in a position of similar scope and responsibility.
Professional experience in the pharmaceutical or medical device industry, working with regulated systems.
Strong communication skills with the ability to lead meetings and interact effectively with stakeholders.
Ability to maintain the validated state of applications in accordance with internal policies and procedures.

Additional Skills & Qualifications

Experience with electronic validation applications to manage validation lifecycle documentation and approvals.
Experience with Medical Device Regulatory Submissions and applications used by Regulatory Affairs teams.
Experience with CSA validation of SaaS applications in a regulated environment.
Experience with CSA or CSV validation of AI models, including risk-based testing and documentation.
Familiarity with electronic Instructions for Use (eIFU) and electronic Prescribing Information solutions.
Exposure to Regulatory Intelligence systems and tools used to monitor and interpret regulatory requirements.
Experience with systems supporting Regulatory Submission and Deficiency management processes.
Strong technical writing background, with the ability to translate complex technical and regulatory concepts into clear, concise documentation.
Comfort working within a large medical device or similarly complex, highly regulated organization.

Work EnvironmentThis role operates in a hybrid work model, with three days per week on-site in an office setting and the remaining time working remotely. You will work standard Monday to Friday hours in a professional, corporate environment within a large medical device organization. The position is primarily office-based and involves regular use of computers, collaboration tools, and electronic validation and regulatory systems. Physical activities include sitting and standing for extended periods, performing general office functions, and occasionally lifting up to twenty-five pounds, as well as bending, stooping, and reaching as needed. The work environment emphasizes collaboration across R&D IT, Regulatory, and Quality teams and supports a structured, process-driven approach to validation and compliance. Job Type & LocationThis is a Contract position based out of Raleigh, NC. Pay and BenefitsThe pay range for this position is $60.00 - $66.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits

available for this temporary role may include the following:

Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Job Type & LocationThis is a Contract position based out of Raleigh, NC. Application DeadlineThis position is anticipated to close on Nov 6, 2026. Workplace TypeThis is a hybrid position in Raleigh,NC.About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

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More about this job

Skills

Technical writing
Communication skills
Decision making
Documentation
Monitor system performance
Change management
Regulatory compliance
Regulatory affairs
Process improvement
Office equipment
Control systems
Computer science
Collaboration
Heavy lifting

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