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Taming Autoimmunity™
IT Validation Engineer
Location
United States
Posted
33 days ago
Salary
$130K - $145K / year
Seniority
Senior
Job Description
IT Validation Engineer
Kyverna Therapeutics
• Execute validation activities for GxP computerized systems using a risk-based Computer Software Assurance (CSA) approach. • Author and maintain validation deliverables, including Validation Plans, Risk Assessments, Test Scripts and Protocols, and Validation Summary Reports. • Support full system lifecycle activities, including implementation, change control, periodic review, and system retirement. • Ensure all validation documentation is inspection-ready and aligned with internal procedures and global regulatory requirements. • Partner with IT and business stakeholders to support onboarding and implementation of new systems. • Provide validation guidance during system selection, configuration, and release to ensure compliance and scalability. • Participate in change control assessments, evaluating the impact of system changes and enhancements on validated state. • Serve as the validation lead for key GxP platforms, including Veeva Vault (eQMS, QualityDocs, Training) and other regulated systems. • Ensure systems remain in a validated state in compliance with 21 CFR Part 11, EU Annex 11, and data integrity principles, including ALCOA+. • Collaborate with IT and system owners to support system enhancements, releases, and ongoing periodic reviews. • Support IT due diligence and qualification of third-party vendors and supplier systems used in GxP environments. • Assess supplier validation packages, documentation, and control frameworks to ensure compliance with internal and regulatory standards. • Partner with Quality to evaluate risks, define mitigation strategies, and maintain effective supplier oversight. • Maintain continuous inspection readiness by ensuring completeness and accuracy of validation documentation, audit trails, and supporting artifacts. • Support internal audits, mock inspections, and regulatory inspections, including direct interaction with agencies such as the U.S. Food and Drug Administration and European Medicines Agency. • Proactively identify compliance gaps and drive remediation efforts to strengthen the overall validation and quality posture. • Act as the primary IT partner to Quality for validation, compliance, and data integrity-related activities. • Collaborate cross-functionally with Quality Systems, Clinical QA, Regulatory, and other GxP functions to align on validation strategy, risk management, and governance. • Support the development and continuous improvement of validation procedures, templates, and processes. • Provide training and guidance to system owners and stakeholders on validation requirements and best practices.
Job Requirements
- Bachelor’s degree in Computer Science, Information Systems, Life Sciences, or a related discipline.
- A minimum of 6 years of experience in IT validation, Computer System Validation (CSV), or GxP-regulated systems within biotechnology, pharmaceutical, or similarly regulated environments.
- Demonstrated hands-on expertise in CSV methodologies, including execution of IQ, OQ, PQ, and UAT activities.
- Strong working knowledge of Computer Software Assurance (CSA) principles, 21 CFR Part 11 and broader GxP regulatory requirements, and data integrity standards, including ALCOA+.
- Proven ability to independently author and manage validation documentation across the full system lifecycle, from planning through execution and final reporting.
- Experience with eQMS, document management systems, and/or clinical systems is preferred.
- Direct experience supporting or owning validation activities for GxP systems such as Veeva Vault, eQMS platforms, or comparable regulated applications.
- Experience performing supplier system assessments and managing vendor-provided validation documentation.
- Strong cross-functional collaboration skills, with a demonstrated ability to partner effectively with Quality, IT, and business stakeholders.
- High level of attention to detail, with a focus on documentation accuracy and inspection readiness.
- Ability to operate with a high degree of ownership, accountability, and autonomy in a fast-paced, regulated environment.
Benefits
- bonus
- benefits
- participation in Company’s stock plan
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Architecture & Engineering Project Assessor (BVTA)
Bureau VeritasAt Bureau Veritas, we are driven by our values of Trusted, Responsible, Ambitious & Humble, and Open & Inclusive. If this resonates with you, we’d love to hear from you.
A WORLD LEADER IN TESTING, INSPECTION & CERTIFICATION SERVICES Bureau Veritas offers dynamic, exciting employment opportunities with an attractive salary/benefit package and an opportunity to play a vital role with a global organization. If you would enjoy working in a dynamic environment and are looking for an opportunity to become part of a stellar team of professionals, we invite you to apply online today. Bureau Veritas is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, citizen status, sexual orientation, genetics, status as a protected veteran, or any other non-job-related characteristics. This position is responsible to ensure equal opportunity in employment in that all persons are treated equally and on the basis of merit, in decisions regarding selection, placement, promotions, training, work assignments, transfers and other personnel actions. City: Remote State: Remote WE are looking for YOU if… you have experience conducting Property Condition Assessments (PCA) and writing technical reports. We are looking for you if you have a strong understanding of ASTM standards and applying them to both walkthroughs and reports. We are looking for you if you have experience with seismic, structural, mechanical, civil, environmental surveys, pre-construction document reviews, construction monitoring, desk reviews, report reviews, or document reviews. We are looking for you if traveling 50% to 75% of the workweek excites you! YOU are looking for US if… you enjoy a fast-paced, work-hard play-hard environment working with industry experts who are also awesome people! 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In lieu of degree, five years of related experience and/or training, or equivalent combination of education and experience. - Valid driver's license required with no significant MVA points/violations (clean driving record). - Personal credit sufficient to charge business travel expenses of up to $3,000 required. - Current Registered Architect or Professional Engineer preferred. - Must be able to meet the physical demands of the job. - Must pass a background check / drug screen. - Excellent verbal and written communication skills PHYSICAL DEMANDS: The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing Onsite / Field Assessor duties, the employee is required to: - Travel by Plane, Motor Vehicle, Train (50%-75% of workweek) to client sites across the U.S. Common patterns of travel include one day on-site followed by one day at home. 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The employee is frequently required to stand, walk, sit, talk and hear. The employee is occasionally required to reach with hands and arms, climb or balance, and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. The noise level in the home or company office environment is usually quiet. Benefits: At Bureau Veritas, we are dedicated to ensuring our employees receive fair and competitive pay, accompanied by comprehensive health and wellness benefits. Here's a breakdown of what we provide: Salary range starting at: $80,000 Annual Incentive Bonus Plan Base Pay is adjusted based on job-related knowledge, skills, experience, and market location. Our Health and Welfare Benefits are designed to meet your needs, eligible on your first day of employment: Medical, Dental, and Vision coverage Company-matched Retirement plan Generous Paid Time Off and Company Holidays Life Insurance and AD&D coverage Short-Term Disability (STD) and Long-Term Disability (LTD) Tuition Assistance, along with optional life and pet insurance Access to Corporate Discounts This information is transparently provided in adherence to several state and local Equal Pay and Pay Transparency Laws, with our base pay determined by market location. Join us at Bureau Veritas, where your well-being and professional growth are our top priorities. If you are an individual with a disability and you would like us to assist you with searching the Careers Page site for employment opportunities and/or assistance with completing your profile and application, please contact us at 1-888-357-7020 or email us with your request to NorthAmericaTA@bureauveritas.com. We are happy to assist you and encourage you to consider Bureau Veritas for your next great career opportunity! If you would like additional information regarding Bureau Veritas' federal obligations in regards to equal employment opportunity, please click the link below: https://www.dol.gov/agencies/ofccp/posters
Architecture & Engineering Project Assessor (BVTA)
Bureau VeritasAt Bureau Veritas, we are driven by our values of Trusted, Responsible, Ambitious & Humble, and Open & Inclusive. If this resonates with you, we’d love to hear from you.
A WORLD LEADER IN TESTING, INSPECTION & CERTIFICATION SERVICES Bureau Veritas offers dynamic, exciting employment opportunities with an attractive salary/benefit package and an opportunity to play a vital role with a global organization. If you would enjoy working in a dynamic environment and are looking for an opportunity to become part of a stellar team of professionals, we invite you to apply online today. Bureau Veritas is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, citizen status, sexual orientation, genetics, status as a protected veteran, or any other non-job-related characteristics. This position is responsible to ensure equal opportunity in employment in that all persons are treated equally and on the basis of merit, in decisions regarding selection, placement, promotions, training, work assignments, transfers and other personnel actions. City: Remote State: Remote WE are looking for YOU if… you have experience conducting Property Condition Assessments (PCA) and writing technical reports. We are looking for you if you have a strong understanding of ASTM standards and applying them to both walkthroughs and reports. We are looking for you if you have experience with seismic, structural, mechanical, civil, environmental surveys, pre-construction document reviews, construction monitoring, desk reviews, report reviews, or document reviews. We are looking for you if traveling 50% to 75% of the workweek excites you! YOU are looking for US if… you enjoy a fast-paced, work-hard play-hard environment working with industry experts who are also awesome people! We are committed to providing our employees with a flexible work environment with equal opportunity for learning and personal growth. At BUREAU VERITAS, we are here to create trust and leave our mark responsibly. If this sounds like you, join the team! You will be primarily responsible for… - Performing Property Condition Assessments (PCAs) nationwide as well as other property related services. - Conducting walk-through surveys and assessments of major building systems, structures and foundations. - Developing proactive solutions and estimating costs to remedy any physical deficiencies and publishing a written report detailing building conditions per ASTM Standards and client-specific scopes of work. QUALIFICATIONS: - Bachelor's degree (B.A. or B.S.) from four-year college or university in related field (Architecture and/or Engineering preferred); minimum of three years of related experience performing Property Condition Assessments (PCAs). In lieu of degree, five years of related experience and/or training, or equivalent combination of education and experience. - Valid driver's license required with no significant MVA points/violations (clean driving record). - Personal credit sufficient to charge business travel expenses of up to $3,000 required. - Current Registered Architect or Professional Engineer preferred. - Must be able to meet the physical demands of the job. - Must pass a background check / drug screen. - Excellent verbal and written communication skills PHYSICAL DEMANDS: The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing Onsite / Field Assessor duties, the employee is required to: - Travel by Plane, Motor Vehicle, Train (50%-75% of workweek) to client sites across the U.S. Common patterns of travel include one day on-site followed by one day at home. Overnight stays away from home may be required, along with weekend travel. - Walk (material part of an 8-hour workday, up to 3 to 4 continuous hours at one time) - Stand (material part of an 8-hour workday, up to 3 to 4 continuous hours at one time) - Sit, Stoop, kneel, crouch, or crawl to observe basement and grade-level crawl spaces, and/or to read equipment data plates when necessary (at least once for each building assessed) - Climb and balance Stairs (at least once for each building assessed) - Climb and balance various types of ladders to access flat roofs/hatch access (at least once for each building assessed) - Repetitive use of hands/fingers for keyboard interaction (frequently) - Reach with hands and arms - Talking and hearing (communicate with onsite contact) - Vision (close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus) - Lift and or move (occasionally up to 40 pounds) - Operate an electronic tablet in the field for live data collection. - Operate a computer (up to 100% of workweek) - Operating a motor vehicle While performing the office/offsite duties of this job: The employee is regularly required to use hands. The employee is frequently required to stand, walk, sit, talk and hear. The employee is occasionally required to reach with hands and arms, climb or balance, and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. The noise level in the home or company office environment is usually quiet. Benefits: At Bureau Veritas, we are dedicated to ensuring our employees receive fair and competitive pay, accompanied by comprehensive health and wellness benefits. Here's a breakdown of what we provide: Salary range starting at: $80,000 Annual Incentive Bonus Plan Base Pay is adjusted based on job-related knowledge, skills, experience, and market location. Our Health and Welfare Benefits are designed to meet your needs, eligible on your first day of employment: Medical, Dental, and Vision coverage Company-matched Retirement plan Generous Paid Time Off and Company Holidays Life Insurance and AD&D coverage Short-Term Disability (STD) and Long-Term Disability (LTD) Tuition Assistance, along with optional life and pet insurance Access to Corporate Discounts This information is transparently provided in adherence to several state and local Equal Pay and Pay Transparency Laws, with our base pay determined by market location. Join us at Bureau Veritas, where your well-being and professional growth are our top priorities. If you are an individual with a disability and you would like us to assist you with searching the Careers Page site for employment opportunities and/or assistance with completing your profile and application, please contact us at 1-888-357-7020 or email us with your request to NorthAmericaTA@bureauveritas.com. We are happy to assist you and encourage you to consider Bureau Veritas for your next great career opportunity! If you would like additional information regarding Bureau Veritas' federal obligations in regards to equal employment opportunity, please click the link below: https://www.dol.gov/agencies/ofccp/posters
Overview Ragnar Benson, a MasTec Company is in search of a Project Engineer to support our passenger and heavy rail construction, mid-to-large size healthcare, higher education and commercial building projects acorss the United States. Travel & Location: You can be based anywhere in the United States. This is a traveling position encompassing work sites across the United States. You have the potential to be placed on a project site located in any state throughout the US. We offer designated per diem in addition to base pay to support and help you cover living expenses during the travel rotation. A company vehicle and fuel card will be provided. Must be capable of up to 75% travel (e.g. 3 weeks or 15 days per month) by automobile (as driver and passenger), commercial airlines, rental vehicles and public transportation and be able to lodge in public facilities. Travel will be necessary to conduct the duties of this job, and the employee must have the ability to drive and have proper licensing. Ragnar Benson Construction is a full-service general contractor specializing in commuter rail, intermodal facilities, and ports. With almost 40 years of experience in the railway industry, we offer various delivery models, including general contracting, construction management, preconstruction, and design-build services. In addition, we specialize in constructing intermodal facilities, classification yards, mechanical repair facilities, fueling facilities, automobile marshaling terminals, and mainline capacity improvements. Focusing on innovation, safety, and environmentally-responsible construction, Ragnar Benson delivers quality work and service. Ragnar Benson is part of the MasTec Clean Energy & Infrastructure (CE&I) business segment. The CE&I segment generates over $4.5 billion in annual revenue, providing construction services across our renewables, industrial, infrastructure, and general building operating groups. Sustainability and safety are foundational to our culture and influence everything we do. MasTec, a minority-owned Fortune 500 company, has shaped the construction industry for more than 90 years. With over 35,000 employees and 400 offices nationwide, we provide flexibility and career growth in dynamic work environments. Join one of the largest construction firms in the country (Engineering News-Record [ENR]: #1 in Power, #17 Top 50 Domestic Heavy Contractors, #20 Transportation Contractor). Responsibilities - Preparing scheduling of subcontractors on site - Receiving and checking quality of materials - Completing QA/QC checklists - Submittals (material approvals) - RFI’s (general questions) - Preparing official documents for the project, routing and finalizing - Preparing projects reports as needed - Back up documentation - Close-outs final quantities - Proposing/ negotiation extra work - Special projects within the Project Management function as necessary - Other duties as assigned by the Project Management Department Qualifications - Bachelor’s Degree preferred (Civil Engineers, Construction Management, or related field preferred); High School Diploma or equivalent required - 2 years of experience in Civil or Industrial Construction is required - Must be capable of up to 75% travel (e.g. 3 weeks or 15 days per month) by automobile (as driver and passenger), commercial airlines, rental vehicles and public transportation and be able to lodge in public facilities. - Travel will be necessary to conduct the duties of this job, and the employee must have the ability to drive and have proper licensing Knowledge, Skills and Abilities - Strong analytical skills - Detail oriented, and good organization skills - Ability to communicate well with others, both written and orally - Proficient in Microsoft Office, Procore and Viewpoint - Proficient in Windows based applications - Thrive in fast-paced environment What's in it for You Financial Wellbeing - Compensation $75,000-$85,000 / year, commensurate with experience - Competitive pay with ongoing performance review and merit increase - 401(k) with company match & Employee Stock Purchase Plan (ESPP) - Flexible spending account (Healthcare & Dependent care) Health & Wellness - Medical, Dental, and Vision insurance (plan choice) - coverage for spouse, domestic partner, and children - Diabetes Management, Telehealth Coverage, Prescription Drug Plan, Pet Insurance, Weight Management Drug Discount - Discounted National Gym Membership Network Family & Lifestyle - Paid Time Off, Paid Holidays, Bereavement Leave - Military Leave, including Benefits Continuation - Employee Assistance Program Planning for the Unexpected - Short and long-term disability, life insurance, and accidental death & dismemberment - Voluntary life insurance, accident, critical illness, hospital indemnity coverage - Emergency Travel Assistance Program - Group legal plan Position may be subject to pre-employment screening, which may include background check and drug testing. Accessibility: If you need accommodation as part of the employment process, contact ceicareers@mastec.com. Due to the high volume of applications received, we are unable to respond to individual requests regarding application status. Please log into your candidate profile for up-to-date information. MasTec, Inc. is an Equal Employment Opportunity Employer. The Company's policy is not to unlawfully discriminate against any applicant or employee on the basis of race, color, sex, sexual orientation, gender identity, religion, national origin, age, disability, genetic information, military status, or any other consideration made unlawful by applicable federal, state, or local laws. The Company also prohibits harassment of applicants and employees based on any of these protected categories. It is also MasTec's policy to comply with all applicable state, federal and local laws respecting consideration of unemployment status in making hiring decisions. Disclaimer: MasTec and our Subsidiaries will never ask prospective employees for any form of payment or money transfer as part of job application or onboarding. We do not ask prospective employees for information about credit cards or personal passwords, and it does not require applicants to purchase equipment or software. Ensure that all recruiter email addresses end in @mastec.com or @talent.icims.com. If you suspect you are the target of a scam, we advise you to contact your local law enforcement agency and report fraud at https://reportfraud.ftc.gov/. MasTec Clean Energy & Infrastructure and our subsidiaries do not work with any third-party recruiters or agencies without a valid signed agreement and partnership with the Corporate Talent Acquisition Team. #LI-DS1 #LI-Remote Service Line RBL-Ragnar Benson, LLC


