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1729 - Construction Manager I
HNTB Corporation
St. Louis, MO
…services on projects of a diverse nature in accordance with design specifications to assure that construction projects are completed in compliance with the drawings and specifications,…
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Mechanical Engineer - Emerging Capabilities (New Product Development)
New Orleans, LA
Collaborate with Engineering, Technical, Manufacturing, and Commercial teams to understand requirements, resolve design questions, and support project execution.
Added 1 min ago
Future Leader Development Associate, Human Resources
Blue Bird Brand
Macon, GA
…buses since its founding in 1927. Our dedicated team members design, engineer and manufacture school buses with a singular focus on safety, reliability, and durability. School buses carry…
Added 1 min ago
Director - Land Development
LJA 2025
Denver, CO
…manage multiple land development projects while coordinating project execution, mentoring staff, and maintaining strong client relationships. You’ll serve as a technical and operational…
Added 1 min ago
Project Manager - Land Development
LJA 2025
Pensacola, FL
POSITION OVERVIEW: As a Project Manager at LJA Land Development, you will be responsible for conceptualizing, interpreting, organizing, executing and coordinating engineering projects…
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Senior Technical Success Manager, Emerging Enterprise - West
Amplitude
Remote, United States
- $168,000 to $252,000 USD / year
…coordination of delivery (e.g. managing internal and partner teams), project…
Added 2 mins ago
SCADA OT ENGINEER
VERSANT POWER
Hampden, ME
Work with field planners, asset management engineers, Engineering Department, Line Department, outside resources and project managers to design and engineer SCADA and device numbering…
Added 3 mins ago
Structural Engineer 3 - Nuclear
Sargent & Lundy
Phoenix, AZ
3+ years of experience working as a member of a project team in the design and analysis of structures, including both AISC steel and ACI concrete designs.
Added 3 mins ago
Lead Mechanical Engineer 1 - Nuclear
Sargent & Lundy
Englewood, CO
You will be involved in nuclear power plant systems design, including preparation or review of:
Added 3 mins ago
Project Engineer - Oil & Gas
Sargent & Lundy
Englewood, CO
The Project Engineer – Oil & Gas is responsible for the planning, coordination, technical oversight, and execution support of engineering projects across S&L’s oil and gas division. This…
Added 3 mins ago
Mechanical Engineer 3 - Energy & Industrial
Sargent & Lundy
Englewood, CO
Knowledge of the practical application of mechanical engineering and technology including applying systems, principles, techniques, procedures, and equipment to a project design
Added 3 mins ago
Electrical Engineer 2 - Energy & Industrial Group
Sargent & Lundy
Englewood, CO
Under the direction of the project lead, you will work in a project team environment with other engineers and designers involved in the design, modification, and analysis of new and…
Added 3 mins ago
Senior Structural Engineer 1 - Energy & Industrial Group
Sargent & Lundy
Englewood, CO
Coordinate and provide guidance to other engineers, project managers, client personnel, and suppliers to ensure a complete and timely design.
Added 3 mins ago
Lead Full-Stack Developer
LMI
United States
LMI is seeking a Lead Full Stack Developer to lead the design, development, integration, and sustainment of a secure, web-based mission data and digital asset management application…
Added 3 mins ago
Staff Cyber Security Engineer
St. Jude Medical, Cardiology Division, I
CA
As the Staff Cyber Security Engineer, you’ll Be on the front lines of the emerging area of medical device cybersecurity manufacturing as an
Added 4 mins ago
Piping Field Engineer - Testing
Bechtel
New Albany, OH
Bechtel is building a semiconductor manufacturing plant in New Albany, Ohio. Bechtel will design and build Phase 1 of the Ohio One project, a total of 2.5 million square feet, including…
Added 4 mins ago
Structural Field Engineer
Bechtel
New Albany, OH
Troubleshoots technical and constructability issues with the design engineer or fabricator, using input from supervision, and documents field changes, RFIs, and nonconformances through the…
Added 4 mins ago
Software Engineer (No Security Clearance Required)
Etegent Technologies, LTD
Beavercreek, OH
Etegent is seeking a Software Engineer to help transition data exploitation algorithms from R&D into useable software to benefit our Department of Defense (DoD) and Intelligence Community…
Added 5 mins ago
Process Engineer
Exyte GmbH
Dallas
The Engineer Process is responsible for supporting and leading process system design activities on projects. Systems may include high-purity gases and chemicals, biologics processing, small…
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Jr Electrical Design Engineer
Actalent
Austin, TX
Job Title: Electrical Design Engineer Location: Austin, TXJob DescriptionThe Electrical Design Engineer supports the planning and design of electrical infrastructure for commercial,…
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Integration And Test Engineer
Actalent
Syracuse, NY
- $92.5 to $112.85 USD / hour
Integration & Test Engineer Integration & Test Engineer will develop and execute advanced testing strategies for software and system-level applications that support electronic warfare,…
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Manufacturing Engineer
Actalent
Chandler, AZ
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Land Surveyor
Actalent
West Fargo, ND
- $40 USD / hour
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Electrical Engineer
Actalent
Downers Grove, IL
- $60 to $70 USD / hour
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Added 5 mins ago
Mechanical Engineer
Actalent
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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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