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F
Senior Robotics Engineer, Mission Autonomy
FieldAI
Irvine, CA
- $180,000 to $220,000 USD / year
Field AI is seeking a rigorous and innovative Senior Robotic Autonomy Engineer for Mission Autonomy to play a vital role in the development of highly advanced robotic and AI systems by…
Added 1 min ago
Operations Quality Engineer II
Medtronic
North Haven, CT
…cross-functional stakeholders to develop and maintain quality systems, resolve complex quality issues, and drive continuous improvement initiatives that support product reliability and…
Added 1 min ago
Quality Engineer II
Medtronic
North Haven, CT
The Quality Engineer II supports the Surgical Sutures Manufacturing business within Medtronic’s Surgical Innovations group and Enterprise Operations. The Quality Engineering function…
Added 1 min ago
F135 Engine Core Upgrade (ECU) Propulsion Systems Analysis Engineering Intern (Summer 2027) (Onsite)
RTX Corporation
east hartford, CT
Within the F135 ECU Program, Engine Design & Systems Integration (ED&SI) is a dynamic engineering organization focused on the development and certification of military, commercial, and…
Added 1 min ago
Data Scientist 1
Baylor Scott & White Health
Hartford, CT
and monitoring. Use validation checks, interaction patterns, feedback, task outcomes, and error analysis to
Added 1 min ago
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Senior QA Automation Engineer - Playwright & Selenium
Cognizant
Hartford, CT
- $50,000 to $92,500 USD / year
We are seeking a Senior QA Automation Engineer - Playwright & Selenium to join our Quality Engineering team supporting critical financial applications. The ideal candidate will have strong…
Added 1 min ago
Core Senior .NET Software Engineer
Evolent
Hartford, CT
The Senior Software Engineer leads the design, development, and deployment of complex software solutions, ensuring scalability and maintainability. This role architects and implements…
Added 3 mins ago
Blue Cruise Core Integration Engineer
Ford Global
Dearborn, MI
…enjoyable and sustainable. Ford’s Advanced Driver Assistance Systems (ADAS) team designs and develops hardware and functional models that provide Best-in-Class behavior for features like…
Added 3 mins ago
Test Engineer - Electrical
Enovation Controls LLC
OK
The Test Engineer – Electrical, within the Engineering team, is responsible for developing, configuring, and executing electrical design verification (DV) and production validation (PV)…
Added 5 mins ago
Sr DAS Support Engineer - Contract
Black Box
United States
The Senior DAS Support Engineer serves as the Level 3 escalation point and technical authority for distributed antenna systems and in-building wireless environments across healthcare and…
Added 6 mins ago
Cybersecurity Engineer
INFINITY SYSTEMS ENGINEERING LLC
Colorado Springs, CO
We are seeking a Cybersecurity Systems Engineer to join our professional engineering team. This position will support cybersecurity assessments and hardening of operational and support…
Added 8 mins ago
SCADA Engineer
Consumers Energy
JACKSON, MI
The SCADA (Supervisory Control and Data Acquisition) Engineer is responsible for designing, configuring, and maintaining SCADA systems that enable real-time monitoring and control of field…
Added 8 mins ago
Lead Full-Stack Developer
LMI
United States
Engineer scalable file upload, ingestion, transfer, processing, and download workflows that reliably accommodate large volumes of images, video, documents, technical files, and structured…
Added 10 mins ago
A
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,…
Added 10 mins ago
A
Process Engineer
Actalent
Scottsdale, AZ
- $100,000 to $130,000 USD / year
Job Title: Senior Manufacturing Process EngineerJob DescriptionThe Senior Manufacturing Process Engineer plays a critical role in developing, validating, and optimizing manufacturing…
Added 10 mins ago
Technical Engineer - Embedded Systems
Doosan Corp
Fargo, ND
Has a deep expertise in embedded systems design and development. Considered a leader and mentor to other engineers. Shares knowledge about design and development of embedded systems.…
Added 10 mins ago
Cybersecurity Engineer
Pueo Business Solutions LLC
McLean, VA
Pueo is seeking an experienced Cybersecurity Engineer to join our unique team of multidisciplined experts onsite in McLean, VA.
Added 10 mins ago
Cybersecurity Engineer
Pueo Business Solutions LLC
McLean, VA
Pueo is seeking an experienced Cybersecurity Engineer to join our unique team of multidisciplined experts onsite in McLean, VA.
Added 11 mins ago
RDK-B Automation Developer
Infosys
United States
Exposure to CI/CD and DevOps practices.We are looking for an experienced QA Engineer with strong expertise in Wi‑Fi, RDK‑B, and Cable Modem (CPE) domains, with a key focus on automation…
Added 11 mins ago
GMP Process Engineer
Research & Diagnostic Systems, Inc.
St. Paul, MN
The GMP Process Engineer partners with Manufacturing, Quality, Validation, and Engineering teams to support daily operations, investigate process deviations, implement corrective actions,…
Added 11 mins ago
Java Test Engineer
Infosys
United States
…development, functional and integration testing, SQL/database validation, CI/CD and Jenkins, defect management, Agile/Scrum, test strategy and…
Added 12 mins ago
Quality Engineer
KOCH INDUSTRIES INC
HUDSON, WI
Added 12 mins ago
Project Engineer - Advanced Development
REHLKO
KOHLER, WI
Added 12 mins ago
Quality Engineer
KOCH INDUSTRIES INC
HUDSON, WI
Added 12 mins ago
Engineer Torque Tool Strategy
S&C ELECTRIC COMPANY
FRANKLIN, WI

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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