CSV Validation Specialist: Instrument Integration

Katalyst-Healthcares-

Saint Paul, MN

Job Description:

We are seeking a CSV Analyst with Instrument Integration & Validation expertise to support validation and compliance of laboratory, manufacturing, and embedded software systems in regulated environments.
The role focuses on the integration layer, ensuring data moves accurately and completely from instruments through Instrument Manager into the LIS and related downstream workflows.
This position serves as a bridge between technical software validation, testing, and regulatory compliance, ensuring systems operate reliably and remain in a validated state in accordance with EMA and GxP requirements.

Roles & Responsibilities:

Validate software used in laboratory and manufacturing instruments in compliance with FDA, EMA, and GxP guidelines.
Develop and execute validation protocols including IQ, OQ, and PQ.
Ensure systems remain in a validated state throughout their lifecycle.
Author and maintain validation documentation such as Validation Plans, Reports, URS, Functional/Design Specifications, and Traceability Matrices.
Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity standards.
Gather and document system requirements.
Develop software specifications, validation test cases, and supporting documentation.
Create infrastructure diagrams, data flow diagrams, and document current system configurations.
Perform functional, integration, regression, and data integrity testing.
Identify, document, and troubleshoot validation deviations.
Conduct root cause analysis and collaborate with cross-functional teams for issue resolution.
Conduct risk assessments (FMEA) to identify and mitigate system risks.
Support change control processes for software updates and enhancements.
Assist in transitioning legacy SOPs to updated IT/software management SOPs.
Perform regulated laboratory validation activities.
Support requirements gathering and documentation.
Author and execute validation test cases.
Perform IQ/OQ/PQ, UAT, and end-to-end testing.
Conduct risk assessments and support change control activities.
Perform technical writing and objective evidence collection.
Verify data integrity across systems.
Support instrument integration workflows.
Work with Instrument Manager or similar middleware.
Validate instrument-to-middleware-to-LIS data flow.
Support LIS, downstream reporting, and QC-related workflows.
Ensure alignment with CAP, CLIA, 21 CFR Part 11, and GAMP risk-based validation expectations.

Requirements:

Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field.
2–5+ years of experience in Computer System Validation (CSV) or software validation within pharmaceutical, biotech, or medical device industries.
Strong understanding of regulatory requirements including FDA, EMA, GMP, 21 CFR Part 11, and GAMP 5.
Hands-on experience with laboratory systems such as LIMS and Chromatography Data Systems (e.g., Empower).
Experience with validation lifecycle processes, documentation standards, and data integrity principles.
Strong regulated laboratory validation experience in Instrument Integration & Validation.

#J-18808-Ljbffr

Apply

Vacancy posted 2 days ago

Similar jobs that could be interesting for youBased on the CSV Validation Specialist: Instrument Integration in Saint Paul, MN vacancy

Validation Engineering
...1707Summary: We are currently looking for an experienced CSV (Computer System Validation) Engineer to join our team in Plymouth, MN.Roles & Responsibilities... ...compliance with FDA, GxP, GMP, 21 CFR Part 11, and data integrity requirements. Support system implementation, upgrades,...
Suggested
Katalyst Healthcares & Life Sciences
Minneapolis, MN
6 days ago
AI-Enabled Cell Therapy CSV Validation Specialist
...Katalyst CRO in the United States is seeking a seasoned CSV professional to lead validation activities for enterprise GxP systems in Cell Therapy projects. You will support validation leads to ensure deliverables and testing align with the Client CSV SOP and quality expectations...
Suggested
Katalyst CRO
Minneapolis, MN
18 hours ago
Senior Manufacturing Engineering
$94.14k - $134.63k
...manufacturing.About the role - you will:Engage in the development and integration of new reader and writer technologies, including Heat-Assisted... ...execute experiments that generate meaningful and statistically valid results.Actively contribute to troubleshooting material,...
Suggested
Full time
Temporary work
Flexible hours
Shift work
Seagate Technology
Bloomington, MN
6 days ago
Validation Engineering
$93.5k
JOB TITLE & Employer Name: Validation Specialist for Harvard Bioscience, Inc. LOCATION: 119-14th Street NW., Suite 100, St. Paul, Minnesota 55112. JOB DUTIES: Develop and implement validation documentation that include Standard Operating Procedures, Master Validation...
Suggested
Remote work
Harvard Bioscience
Saint Paul, MN
1 day ago
Remote-Eligible Validation Specialist (GMP/GLP)
...Harvard Bioscience, Inc. is seeking a Validation Specialist to develop and implement validation documentation for two proprietary software applications in a regulated environment. You will perform risk assessments, assist with audits, and maintain compliance with SOPs...
Suggested
Remote work
Harvard Bioscience
Saint Paul, MN
15 hours ago
Cleaning Validation Specialist
...Cleaning Validation SpecialistOur client, a leading biologics manufacturing company, is seeking an experienced Cleaning Validation Specialist to support cleaning validation activities for equipment upgrade projects within a cGMP manufacturing environment. This role will...
Full time
For contractors
Katalyst HealthCares & Life Sciences
Saint Paul, MN
3 days ago
Instrumentation and Control Engineer
...more impact together. Role description: Arcadis is seeking an experienced Instrumentation & Controls Engineer to join our semiconductor sector. This individual will be an integral part of the engineering design group and work with other designers, engineers, and...
Full time
Part time
Work at office
Remote work
Relocation
Jobrapido
Saint Paul, MN
1 day ago
Senior Digital / Mixed-Signal IC Design or Verification Engineer
$109.7k - $175.5k
...verification, static timing analysis, and place and route. Support integrating the digital core with analog circuitry into a completed... ...new methodologies (e.g., SVA, UVM/OVM) to reduce mixed-signal validation bottlenecks.Lead initiatives to explore and integrate modern...
Full time
Local area
Worldwide
Broadcom
Saint Paul, MN
7 days ago
Senior Continuous Integration (CI) Engineer
...engineers do meaningful work.We are seeking a Senior Continuous Integration (CI) Engineer to design, maintain and continuously improve... ...practices.Experience with software release documentation or validation of software development tools in a regulated environment.Requisition...
Hourly pay
Work at office
Local area
Relocation
Relocation package
Shift work
Boston Scientific Corporation
Saint Paul, MN
6 days ago
Senior Manufacturing Engineering- Contractor
$78k - $156k
...Interfaces with Quality and Research and Development organizations to integrate new products or processes into the existing manufacturing area... ...of the company Conduct Process FMEAs and Process Validations. Provide guidance and technical mentorship to engineers and...
For contractors
Work experience placement
Worldwide
Abbott
Saint Paul, MN
8 days ago
Senior Integrations Engineer
...The Overview Our Senior Integrations Engineer is a high-impact technical role where you’ll architect, build, and deploy scalable integrations connecting HubSpot to leading CRMs, ERPs, accounting systems, and custom APIs. If you thrive on solving complex technical...
Jobrapido
Saint Paul, MN
19 hours ago
Process Mechanical Engineer - Water / Wastewater Industry - Saint Paul, MN
$95k - $129k
...etc. is required.Experience closely coordinating with architects and structural, electrical, instrumentation and controls, and building-mechanical engineers to deliver integrated design solutions.Experience directing BIM professionals in developing 3D models and...
Full time
Contract work
Temporary work
For contractors
Brown and Caldwell
Saint Paul, MN
8 days ago
Manufacturing engineering - systems
...Job Title The role focuses on integration of the legacy CSI quality management system into the Client quality management system, with... ...is expected to support documentation harmonization, validation execution, and contribute to manufacturing engineering initiatives...
Katalyst HealthCares & Life Sciences
Saint Paul, MN
4 days ago
Senior Manufacturing Engineering
...manufacturing requirements and emerging test and process technologies. Quality Integration & Compliance Own quality documentation for assigned product lines, including familiarity with IQ/OQ validation work. Partner directly with Quality Engineering to quickly...
Contract work
Work at office
Local area
Forj Medical
Saint Paul, MN
19 hours ago
Test Automation Engineering As...
$73.45k - $132.78k
...maintain reusable test libraries and utilities for the L-CAP test infrastructure Integrate automated tests into CI/CD pipelines ensuring continuous quality gates Conduct performance testing to validate system behavior under load and stress conditions Execute integration...
Full time
Contract work
Remote work
Work from home
Leidos
Saint Paul, MN
9 days ago
Test Engineering M/F
$74.47k - $105.06k
..., and optimizing test throughput.Create detailed electrical schematics and drawings in collaboration with a test technician.Integrate instruments such as DMMs, power supplies, optical power meters, and communication interfaces (Ethernet, RS232).Integrate automation equipment...
Full time
Work at office
Banner Engineering
Minneapolis, MN
7 days ago
Senior Manufacturing Engineer
...toolpaths, and keep the floor running at spec. Review CMM data and apply statistical methods to evaluate and improve processes, integrating findings into MES work instructions. Participate in the qualification and training of production team members, including...
Day shift
Jobrapido
Saint Paul, MN
2 days ago
Instrumentation Engineer
$110k - $165k
...Electrical Engineer III - Cryogenic Instrumentation About xLight xLight is building the world's most powerful laser to revolutionize... ...to learn and grow — guided by our core values of Respect, Integrity, Creativity, and Engineering Excellence. We don't just hire for...
Work at office
Immediate start
Flexible hours
Jobrapido
Minneapolis, MN
3 days ago
Senior Data Integration Programmer
$120k - $160k
...deliver scalable data solutions Ensure the integrity of financial data through regular audits... ...sources, including databases, APIs, CSV, Excel, TXT, XML, and JSON filesDevelop,... ...tables, views, and indexesImplement data validation and cleansing processes to ensure high data...
Full time
For contractors
Local area
Perkins&Will
Minneapolis, MN
7 days ago
AI Validation Lead Contractor
...Job Title: AI Validation Lead Contractor Location: Remote/WFH.. (First week is onsite at nearer location) Duration: 02 months + possible... ...defect management. Perform AI/ML model governance, data integrity assessments, and compliance reviews to support audit readiness...
Contract work
For contractors
Work at office
Remote work
Work from home
Charter Global
Saint Paul, MN
5 days ago
Senior Systems Verification and Validation Engineer
...Reference26-02012 Summary: As a Senior Systems Verification and Validation Engineer (contract) on Vantive's Acute Therapies V&V team,... .... Define and execute test strategies for system-level, integration, and hardware-level testing. Understand the end-to-end verification...
Contract work
Immediate start
Katalyst Healthcares & Life Sciences
Minneapolis, MN
6 days ago
Automation Technician Commissioning Specialist
$36 - $45 per hour
...teams by executing commissioning, system validation, and industrial networking activities... ..., and supporting PLC and network integration that directly impacts system performance... ...understanding of control systems, field instrumentation, and electrical fundamentalsHands-on...
Full time
Local area
Remote work
Knobelsdorff
Saint Paul, MN
3 days ago
Senior Technical Operations Engineer - Reagent Manufacturing
$100.8k - $165.6k
...ELISA kits, Luminex assays, cell culture media, protein analysis instrument reagents, and other products used in academic research,... ...analysis, and manufacturing experience. Equipment and Process Integration Evaluate the suitability of existing equipment for current and...
Full time
Temporary work
Internship
Work at office
Worldwide
Flexible hours
Bio-Techne
Minneapolis, MN
7 days ago
Senior Test Automation Engineering
...areas served. The role involves defining and analyzing product validation for new and/or modified applications. The individual will... ...relational databases, tool APIs, and experience in building tool integrations. A broad knowledge of principles, practices, and procedures...
Remote work
Jobrapido
Saint Paul, MN
4 days ago
Principal IC SoC Integration and Design Engineer
...Principal IC SoC Integration and Design Engineer Broadcom's ASIC Product Division is seeking experienced professionals for SoC and IP... ...Lead a team in simulation, synthesis, formal verification, and validation of designs. Collaborate with internal and external teams to...
AnySilicon
Mendota Heights, MN
3 days ago
Manufacturing and Technology Innovation Engineering Intern
$19 - $31 per hour
...work of farmers and builders everywhere. With a growing global population and increased demands on resources, our products are instrumental to feeding and sheltering the world. From developing products that run on alternative power to productivity-enhancing precision...
Full time
Summer work
Internship
CNH
Saint Paul, MN
1 day ago
Systems Integration & Test Engineering Lead
$149.83k - $158.02k
...our facilities, U.S. citizenship is required. Responsibilities for this Position ROLE AND POSITION OBJECTIVES:As a Systems Integration and Test (I&T) Engineering Lead for General Dynamics Missions Systems, you’ll lead a cross functional team responsible for...
Flexible hours
General Dynamics Mission Systems
Bloomington, MN
7 days ago
Field Service Engineer - Additive Manufacturing (Aerosol Jet Technology)
...level of service.Key ResponsibilitiesInstall, commission, and validate additive manufacturing systems at customer sitesTroubleshoot and... ..., or advanced manufacturing preferredWorking knowledge of integrated systems (mechanical, electrical, and software)Strong troubleshooting...
Optomec
Saint Paul, MN
4 days ago
Electrical Controls Engineer - Pharmaceutical Manufacturing
...with Process Engineering, Automation, Maintenance, Quality, Validation, Operations, IT/OT, and vendors to deliver safe, compliant, and... ...usability, and cost performance. Support equipment-data integration with manufacturing systems, historians, recipe management,...
Casual work
Work at office
Monday to Friday
LTS Lohmann Therapy
Saint Paul, MN
4 days ago
Senior ASIC Design Verification Engineer - Slingshot
...SystemVerilog and UVM testbench components, including bus functional models that drive and monitor stimulus.Plan and implement block and integration level scoreboards and checkers to verify functional behavior.Write and analyze functional coverage, providing input to block...
Full time
Work experience placement
Work at office
Local area
Immediate start
2 days per week
Hewlett Packard Enterprise
Minneapolis, MN
4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to CSV Validation Specialist: Instrument Integration. Be the first to apply!