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Senior Developer – MuleSoft Data Integrations
Forgent
Remote, United States
The ideal candidate is a hands-on engineer with deep MuleSoft expertise who can also set standards, guide architecture decisions, and mentor others. As Forgent Power grows across sites and…
Added just now
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Senior Software Engineer
Caliola Engineering, LLC
Colorado Springs, CO
- $135,000 to $165,000 USD / year
Caliola Engineering is seeking a Senior Software Engineer to build software that solves complex, meaningful problems in support of mission-critical applications. You will work alongside a…
Added 1 min ago
Senior Python Backend Software Engineer III
JPMC page
Houston, TX
As a Software Engineer at JPMorganChase within the Corporate Sector, you are an integral part of an agile team that works to enhance, build, and deliver trusted market-leading technology…
Added 1 min ago
Client Support Engineer III
ADVANCED NETWORK MANAGEMENT INC
New Mexico, NM
Welcome to ANM. This application is the first step in completing your onboarding as our new Client Support Engineer III. Please review the role job description below and complete the…
Added 1 min ago
Site Reliability Engineer II
Navan
CA or San Francisco, CA · Palo Alto, CA
…challenges ahead and we’re looking for a passionate Site Reliability Engineer to join our team remotely in Dallas, TX or Austin, TX. As an SRE you will design and develop tooling,…
Added 2 mins ago
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Electrical Test Engineer
Actalent
Golden Valley, MN
- $45 to $65 USD / hour
Electrical Test Engineer We are seeking a Test Engineer to lead system verification, reliability validation, and test strategy development for complex robotic and electro-mechanical…
Added 2 mins ago
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Software Test Engineer
Actalent
Owatonna, MN
- $55 to $68 USD / hour
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Added 2 mins ago
Mechanical Engineer
Actalent
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Support product development from concept through production release
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Hardware Engineer
Actalent
Redmond, WA
- $60 to $70 USD / hour
…optics.1. Operating hardware prototypes2. Software or Electrical engineer degree is a must3. fine-pitch soldering 02014. lab environmentJob DescriptionThe Hardware Engineer will work in a…
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Senior Mechanical Engineer
Actalent
Bellevue, WA
Job Title: Mechanical EngineerJob DescriptionWe are seeking a hands-on Mechanical Engineer to advance cutting-edge robotics hardware in a full-time, on-site role in Bellevue, WA. You will…
Added 2 mins ago
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Electrical Engineer
Actalent
Poway, CA
- $120,000 to $200,000 USD / year
…Weapons Systems. This position requires a highly technical engineer with strong project management skills, acting as the primary representative of the Electrical Engineering department to…
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Mechanical Engineer
Actalent
Chandler, AZ
…emphasis on Siemens NX, to develop and refine designs that support advanced aerospace and defense applications. The position offers the opportunity to contribute to launch vehicle and…
Added 2 mins ago
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Remote PCB Layout Engineer (Cadence Needed)
Actalent
Waukesha, WI
- $50 to $75 USD / hour
…files, drill files, assembly drawings, fabrication notes, and support DFM, DFA, and DFT reviews with fabricators and contract…
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Test Engineer
Actalent
Burnsville, MN
- $38 to $47 USD / hour
Job Title: Test EngineerJob DescriptionThe Test Engineer performs end-to-end test engineering activities across all product test stages, from requirements definition and test planning to…
Added 2 mins ago
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Test Engineer
Actalent
Burnsville, MN
- $38 to $47 USD / hour
Job Title: Test EngineerJob DescriptionThe Test Engineer performs end-to-end test engineering activities across all product test stages, from requirements definition and test planning to…
Added 3 mins ago
Lead Quality Engineer
Humana
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The Lead Quality Engineer leads the quality assurance and testing strategy for Medicaid Clinical platforms and integrations, ensuring solutions meet business requirements and operate…
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Manufacturing Engineer II
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As a Manufacturing Engineer at Jabil, you'll have the opportunity to turn engineering concepts into practical improvements on the manufacturing floor. From improving line balance and…
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P&C Engineer/Engineering Technologist Associate - P&C Engineer/Engineering Technologist Principal
AEP Service Corporation
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…level engineering work activities and projects requiring the application of engineering knowledge in a safe, effective, efficient and economic accomplishment of assigned…
Added 4 mins ago
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Senior Product Security Engineer
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- $296,000 to $395,000 USD / year
As a Senior Security Engineer on Product Security, you'll make sure the right security decisions get made in everything Lambda sells, from the network and cluster infrastructure in our data…
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Staff Software Engineer
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Transmission Services Engineer
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Site Reliability Engineer II
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Seattle, WA
As a Site Reliability Engineer on the Kubernetes team in Axon's Compute Platform Engineering (CPE) organization, you'll help run and evolve the platform that Axon's products run on: a…
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Site Reliability Engineer II
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Staff Full-stack Engineer - Shopping (Remote-eligible)
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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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