computer system validation csv engineer jobs

Computer System Validation - CSV Engineer

Remote or New Jersey

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Today

Roles & Responsibilities: Minimum 8+ years of relevant experience; can work independently and guide/mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance's and industry standards (i.e., GAMP) Experience in writing and executing documen

Full-time

Computer system validation Engineer (CSV)

Bridgewater, New Jersey

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Today

Roles & Responsibilities: Experience designing, implementing, and operating IT risk management, IT quality and IT compliance activities in a life sciences organization, with particular focus on GxP, IT internal controls, SDLC management. Experience designing, implementing, and navigating waterfall and agile SDLC (System Development Life Cycle). Experience in SAP/ERP Validation and test management. Experience leading IT risk, IT quality and IT compliance transformational programs. Experience in e

Full-time

Computer System Validation Engineer

Bothell, Washington

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Today

Job Description: The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is an individual contributor. The CSV Contractor will partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle. The CSV Contractor has primary responsibility to ensure that the tasks supp

Full-time

Computer System Validation Engineer

New Jersey

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Today

Roles & Responsibilities: Bachelor's degree in computer science, Engineering, Life Sciences, or related field. 3-7 years of experience in CSV within pharmaceutical, biotech, or medical device industries. Strong knowledge of GAMP 5, FDA 21 CFR Part 11, Annex 11, and related guidelines. Experience with ERP, LIMS, MES, or other GxP systems. Extensive Experience in HPALM with Manual testing. Deep knowledge in Defect Management Life cycle. Proficient in writing validation protocols, reports, and SOPs

Full-time

Computer System Validation (CSV) Engineer

Remote or Massachusetts

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Today

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's degree

Full-time

Lead/Sr Computer System Validation Engineer

Muskegon, Michigan

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Today

Responsibilities: The CSV Lead manages quality control checks on engineering project work. The CSV Lead will have 10 plus years of experience of automation systems computer systems validation in a GMP environment. The CSV Lead will be responsible to assist Client in designing the validation strategy for the overall project and to coordinate production of the required CSV protocols. The CSV Lead will provide leadership to the CSV team members in reviewing CSV protocols for the various streams and

Full-time

Computer Systems Quality Assurance (CSQA) with Validation (CSV)

Indianapolis, Indiana

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4d ago

Job Title: Computer Systems Quality Assurance (CSQA) with Validation (CSV) Location: Indianapolis, IN (Onsite) Duration: 12+ Months Job Description: Please not that 1 F2F round is mandatory. Mandatory skills: IT CSV Validation of IT systems IT QA / QA eCompliance Manager Experience with Veeva Quality Docs, ServiceNow, JIRA and HP ALM Pharma industry experience is mandatory Medical device experience is good to have This Computer Systems Quality Assurance role will be responsible for supporting

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Full-time, Third Party, Contract

$DOE

Project Manager manufacturing

Evansville, Indiana

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9d ago

Job : Project Manager with Manufacturing Domain Location: Evansville, IN, Onsite Contract: C2C & W2 We are seeking a skilled and driven Project Manager with experience in manufacturing environments to lead the implementation of Connected Worker and OEE (Overall Equipment Effectiveness) solutions across multiple manufacturing sites. This role will be responsible for end-to-end coordination, ensuring on-time and on-budget delivery while aligning with IT, functional, and compliance teams to meet gl

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Contract, Third Party

$70 - $75

SAP Validation consultant

No location provided

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4d ago

12+ years Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterfall methodology-based software development Compliance and has prior experience in Computer System Valid

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Third Party, Contract

Depends on Experience

CSV Engineer Spring Co-Op

Wilson, North Carolina

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Today

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Full-time

Computerized Systems Validation Engineer (CSV) Engineer

Swiftwater, Pennsylvania

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Today

Job Title: Computerized Systems Validation Engineer (CSV) Engineer Location: Swiftwater, PA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Sanofi is an innovative global healthcare company with one purpose: to pursue scienti

Full-time

USD 84,000.00 - 121,333.33 per year

Validation Engineer/CSV Engineer

Walnut Creek, California

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Today

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicability

Full-time

Technical Writer/Validation Specialist

Lansdale, Pennsylvania

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2d ago

Develop and maintain SOPs, user manuals, validation protocols, and regulatory submission documents. Translate complex scientific and technical concepts into clear, concise documentation. Collaborate with SMEs to gather and verify technical information. Ensure documentation complies with industry standards (GxP, ISO, ICH). Manage document lifecycle using electronic document management systems (EDMS). Author and execute validation protocols (IQ/OQ/PQ) for equipment, software, and processes. Perfor

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Contract

Depends on Experience

Computer Systems Validation Engineer

Bethlehem, Pennsylvania

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Today

Job Description: We're seeking an experienced Computer Systems Validation (CSV) professional to join our team and lead end-to-end validation activities supporting laboratory system upgrades and data integrity initiatives. This role is ideal for someone with a strong background in regulated environments and hands-on experience with modern lab software and instrumentation. This is a short-term contract assignment running through September and requires individuals to work onsite. Responsibilities:

Full-time

Empower CDS Administration Support Lead - Alameda, CA - Full Time

Alameda, California

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Today

I hope you are doing well, Please share your updated profile if you are interested in the below role. Our client seeks an Empower CDS Administration Support Lead for a Full Time project in Alameda, CA . Below is the detailed requirement Job Title: Empower CDS Administration Support Lead Work location : Alameda, CA Duration: Full Time (Permanent) Job Description: Bachelor's degree preferably in Computer Science, Information technology, Computer Engineering, or related IT discipline or equiva

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Full-time

$DOE

Quality Assurance Engineer "GMP/GXPs"

Hybrid in Raritan, New Jersey

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4d ago

Greetings!! We have an urgent job opportunity with one of our clients for a Software Quality Assurance. If interested, please respond back to me with the below-required details or appreciate it if you would be able to refer an ex-colleague/team member/friend looking for similar roles. CardinalIT offers a referral bonus of $500 for each such referral, to show gratitude and appreciation for this gesture. Updated Resume:Expected Hourly Rates on W2:Availability to start: - Position: Software Qualit

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Contract

Depends on Experience

SDMS Validation Engineer

Remote

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23d ago

Role: Scientific Data Management System (SDMS) Validation Engineer Location: NEAR SHORE - South America/Canada Length: Long term rolling contract CSV engineers and for the applications: Discoverant, BIOVIA ELN, SDMS, Empower, LabX, SoftMax Pro. Job Description: Job Overview: The SDMS (Scientific Data Management System) Validation Engineer is responsible for the qualification, validation, and compliance of scientific data management systems within laboratory environments, particularly in regula

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Contract

$30 - $35

Senior CSV Engineer

Remote or Massachusetts

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Today

Job Description: We are looking for a Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Client's facilities, utilities, and equipment for the qc lab validation project. This role will focus on EMS, Client, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, Sicknotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements. The CSV Engineer will obtain documentatio

Full-time

System Validation Engineer

Santa Clara, California

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Today

Full-time

Software Validation Engineer

Plymouth, Minnesota

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Today

Roles & Responsibilities: Bachelor's degree in computer science, Information Technology, Electronics Engineering, or a related field. Minimum 5-8 years of experience in software validation, preferably within the medical device, pharmaceutical, or regulated healthcare industries. Strong understanding of software development lifecycle (SDLC) methodologies, validation planning, risk management, and quality assurance principles. Experience in handling SW development and verification tools. Good expo

Full-time

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computer system validation csv engineer jobs