CSV Validation Specialist: Instrument Integration

Katalyst-Healthcares-

Bridgeport, CT

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 3 days ago

Similar jobs that could be interesting for youBased on the CSV Validation Specialist: Instrument Integration in Bridgeport, CT vacancy

Validation Engineering
...Computer System Validation SpecialistThis role will focus on the Computer System Validation (CSV) activities for enterprise GxP systems, specifically for a critical set... ...environments.5+ years of experience in Data Integrity/ALCOA+ principles.5+ years of experience with...
Suggested
Katalyst HealthCares & Life Sciences
Bridgeport, CT
3 days ago
Senior Software Verification Engineer
$110.3k - $204.9k
...Description What We’re Doing At Lockheed Martin, innovation and integrity drive everything we do. Within Rotary and Mission Systems, our... ..., and test reports; execute integration, verification, and validation (IV&V) activities in a software‑development lab environment....
Suggested
Full time
Temporary work
Work experience placement
Flexible hours
Lockheed Martin
Stratford, CT
8 hours ago
Manufacturing Engineering, Assembly
$50 per hour
...fulfilling life at and outside of work. At Lockheed Martin, we place an emphasis on empowering our employees by fostering innovation, integrity, and exemplifying the epitome of corporate responsibility. Your Mission is Ours.Proficient in AI prompting as it applies to this...
Suggested
Full time
Temporary work
Work experience placement
Casual work
Flexible hours
Shift work
Weekend work
Lockheed Martin
Stratford, CT
2 days ago
Manufacturing Engineer - E2
$50 per hour
...fulfilling life at and outside of work. At Lockheed Martin, we place an emphasis on empowering our employees by fostering innovation, integrity, and exemplifying the epitome of corporate responsibility. Your Mission is Ours.Performs in a collaborative environment to develop...
Suggested
Full time
Temporary work
Work experience placement
Casual work
Flexible hours
Lockheed Martin
Stratford, CT
3 days ago
Principal Mechanical Engineer - Instruments
...surgery system that uses highly complex mechanics, replaceable instruments and accessories, and enhanced three-dimensional visualization... ...performance and ensure design outputs are successfully integrated into effective system designs.Develop simulation or characterization...
Suggested
Local area
Worldwide
Flexible hours
Intuitive Surgical
Orange, CT
3 days ago
Engineering & Manufacturing Recruiter
$60k - $65k
...with resources designed to support well-being and career development.We have built a culture fostered on entrepreneurial spirit, integrity, teamwork, and transparency. If you are energized by connecting people to opportunity, excited by emerging technologies, and motivated...
Full time
Onward Search
Fairfield, CT
5 days ago
Advanced Industrial Engineer Stf - E4
$50 per hour
...design and build the world’s most advanced helicopters, supporting both military and commercial customers. Our Dynamic Components Integrated Product Team plays a crucial role in optimizing manufacturing efficiency, ensuring we meet the demands of today while preparing...
Full time
Temporary work
Work experience placement
Casual work
Worldwide
Flexible hours
Lockheed Martin
Stratford, CT
2 days ago
Packaging Test Engineer
...packaging performance testing, product qualification, and packaging validation to ensure compliance with applicable industry standards and... ...laboratory testing equipment, evaluating packaging integrity and functionality, developing testing procedures, maintaining...
Full time
Equity Packaging Inc. - North America
Bridgeport, CT
4 days ago
Senior Operations Engineering
$50 per hour
...Strong business acumen, with robust understanding of business strategy and financials.Experience supporting the coordination and integration of company-planned IT system changes with minimum support disruption to customers.Strong resilience, maturity, and stress management...
Full time
Contract work
Temporary work
Work experience placement
Casual work
Flexible hours
Lockheed Martin
Stratford, CT
3 days ago
Operations - Engineering/production
$50 per hour
...Aerospace and Defense manufacturing processes, business models, strategy and financials. Experience supporting the coordination and integration of company-planned IT system changes with minimum support disruption to customers. Pay InformationFull-Time Salary Range: $145100...
Full time
Temporary work
Part time
Work experience placement
Casual work
Flexible hours
Lockheed Martin
Stratford, CT
2 days ago
Electrical/Electronic Engineering Tech Senior
$101.48k - $135.3k
...opportunities to contribute to surgical devices and instruments across the broader women’s health domain... ...and Gynecology (OBGYN).CooperSurgical’s integrated approach—combining Front-End Innovation,... ...CooperSurgical for this position and a valid agreement with CooperSurgical is in...
CooperSurgical
Trumbull, CT
2 days ago
Sr. Process Engineer (Cheese & Liquid Systems)
...functional collaboration skillsIdeal Candidate Profile:Someone currently in a process engineering role at a dairy equipment OEM, system integrator, dairy co-op, or cheese plant who wants design-heavy, customer-facing project work with variety and travel. Must understand...
Remote work
Technology Recruiting Solutions
Stratford, CT
5 days ago
Manufacturing Engineering Planning
$50 per hour
Requisition ID: 16962ERP Eligible?: YesERP amount: $50 LMRecognitionRelocation: PossibleType: ExemptShift: 1Clearance Prior to Start: NoneFinal Clearance: NonePay Transparency: $118,000.00 - $219,100.00Experience Level: Experienced ProfessionalFT/PT/Casual: FullTimeDepartment...
Full time
Temporary work
Work experience placement
Casual work
Work at office
Flexible hours
Shift work
Weekend work
Lockheed Martin
Stratford, CT
2 days ago
Senior Observability Engineer Telemetry & Automation
...Subway Headquarters seeks a Sr. Engineer, Observability, to own instrumentation across servers, networks, cloud services, and applications.... ...technical influence, mentor teams, and collaborate on CI/CD integration, incident response, and service reviews while advancing a...
Franchise World Headquarters, LLC
Shelton, CT
4 days ago
Chapter Next Returnship - Electrical Design/ Manufacturing Engineer
$31.49 - $58.51 per hour
Requisition ID: 2422ERP Eligible?: NoERP amount: N/ARelocation: NoType: Non-ExemptShift: 1Clearance Prior to Start: NoneFinal Clearance: NonePay Transparency: $31.49 - $58.51Experience Level: Hourly/Non-ExemptFT/PT/Casual: PartTimeDepartment: RMS Sikorsky CoreBusiness Unit...
Hourly pay
Full time
Temporary work
Work experience placement
Casual work
Work at office
Flexible hours
Lockheed Martin
Stratford, CT
3 days ago
Manufacturing Engineering
$65.5k - $121.7k
...procedure development, process proofs, BOM/End Item maintenance, support of Digital Transformation projects and improve data capture for integration with data analytics. Basic Qualifications Bachelor's degree in manufacturing or mechanical engineering or similar...
Full time
Temporary work
Work experience placement
Flexible hours
Lockheed Martin Corporation
Shelton, CT
3 days ago
NDT/NDI Test Engineer Sr - E3
$50 per hour
...Audits NDT inspection facilities. Provides recommendations on specifications, capabilities, limitations, and benefits of NDT methods. Validates non-destructive callouts on engineering drawings. Develops course material and trains NDT inspectors in accordance with industry...
Full time
Temporary work
Work experience placement
Casual work
Flexible hours
Lockheed Martin
Stratford, CT
5 days ago
Manufacturing Engineering College Intern
$22.66 - $31.67 per hour
...processes including Additive Manufacturing, Automation and Robotics. Collaborate on producibility reviews of design concepts as well as validation initiatives to ensure product and process conformity. Utilize Data Analytics to improve productivity resulting in more reliable,...
Full time
Temporary work
Work experience placement
Internship
Flexible hours
Lockheed Martin Corporation
Stratford, CT
1 day ago
Manufacturing Engineer Intern | Flexible Schedules & Growth
...instructions for rotors and housings and assist with machining, heat treating, and quality checks. You will gain exposure to 3D modeling, GD&T, and Lean principles while contributing to data-driven productivity improvements and process validation initiatives. #J-18808-Ljbffr...
Internship
Flexible hours
Lockheed Martin Corporation
Stratford, CT
1 day ago
Senior Industrial Engineering
$50 per hour
Requisition ID: 18149ERP Eligible?: YesERP amount: $50 LMRecognitionRelocation: PossibleType: ExemptShift: 1Clearance Prior to Start: NoneFinal Clearance: NonePay Transparency: $95,900.00 - $178,100.00Experience Level: Experienced ProfessionalFT/PT/Casual: FullTimeDepartment...
Full time
Temporary work
Work experience placement
Casual work
Work at office
Worldwide
Flexible hours
Lockheed Martin
Stratford, CT
2 days ago
Industrial Engineer
$50 per hour
Requisition ID: 2413ERP Eligible?: YesERP amount: $50 LMRecognitionRelocation: PossibleType: ExemptShift: 1Clearance Prior to Start: NoneFinal Clearance: NonePay Transparency: $79,300.00 - $147,300.00Experience Level: Experienced ProfessionalFT/PT/Casual: FullTimeDepartment...
Full time
Temporary work
Work experience placement
Casual work
Flexible hours
Lockheed Martin
Stratford, CT
5 days ago
Industrial Engineering Sr Mgr - L6
$50 per hour
Requisition ID: 15150ERP Eligible?: YesERP amount: $50 LMRecognitionRelocation: PossibleType: LeaderShift: 1Clearance Prior to Start: NoneFinal Clearance: NonePay Transparency: $178,500.00 - $331,500.00Experience Level: Experienced ProfessionalFT/PT/Casual: FullTimeDepartment...
Full time
Temporary work
Work experience placement
Casual work
Flexible hours
Lockheed Martin
Stratford, CT
3 days ago
Industrial Engineer Stf - E4
$50 per hour
Requisition ID: 19896ERP Eligible?: YesERP amount: $50 LMRecognitionRelocation: PossibleType: ExemptShift: 1Clearance Prior to Start: NoneFinal Clearance: NonePay Transparency: $118,000.00 - $219,100.00Experience Level: Experienced ProfessionalFT/PT/Casual: FullTimeDepartment...
Full time
Temporary work
Work experience placement
Casual work
Flexible hours
Lockheed Martin
Stratford, CT
1 day ago
Brock Grain Systems Manufacturing Engineer
...and the ability to easily get along with others is a huge plus for this role. Core Values that Apply to All Positions: - Integrity in all things - Customers are why we exist - Profitability is a must - Excellence in all we do - People make the difference...
Full time
Work at office
CTB
Milford, CT
5 days ago
Engineering Manager - Sheet Metal Manufacturing
...departments Assist with customer technical reviews and support first‑article inspections, new product launches, and production validation activities as needed Cross‑Functional Collaboration Partner with Production to resolve day‑to‑day manufacturing...
Full time
Immediate start
Relocation
Monday to Friday
Day shift
Top Prospect Group
Stratford, CT
1 day ago
Manufacturing Engineering Electrical/Electronic
...Responsibilities and Duties: · Contribute to the design, development and integration of electrical systems. · Develop prototypes of electronic... ...improve technical performance. · Support verification and validation (V&V) of hardware and embedded software. · Transferring...
Full time
Contract work
Work at office
KUBTEC Medical
Stratford, CT
2 days ago
Project Engineer Sr Stf - E5
$50 per hour
...impacting suppliers• Provide technical input for supplier councils, sourcing boards, and executive reviews• Virtual Capability Centers• Integrated Product TeamsContinuous Improvement & Standards• Help define and maintain:o Machining capability standardso Supplier technical...
Full time
Temporary work
Work experience placement
Casual work
Flexible hours
Lockheed Martin
Stratford, CT
1 day ago
ISSM / Cybersecurity Technologist
$50 per hour
...tools that support the governance and risk management of classified systems, infrastructure, and tools, ensuring the confidentiality, integrity, and availability of classified assets. The selected candidate will also help lead advanced risk governance operations to...
Full time
Temporary work
Work experience placement
Casual work
Flexible hours
Lockheed Martin
Bridgeport, CT
5 days ago
Quality Engineering Temp
$118k - $219.1k
...Rotary and Mission Systems, we are inspired by innovation and integrity. We believe that by applying the highest standards of business... ...and organizational updatesAs a Quality Continuous Improvement Specialist:Serve as a key catalyst for change, partnering with Quality, Operations...
Full time
Temporary work
Work experience placement
Casual work
Flexible hours
Night shift
Lockheed Martin
Stratford, CT
4 days ago
Echo Technologist (RCS) / Cardiology Diag (Per Diem)
...St. Vincent's is the first hospital in Fairfield County to be integrated into the Hartford HealthCare network and is the system's second... ...Registration: RCS by CCI or RDCS by ARDMS certification required. Valid CPR certification required. Work Experience: One year of...
Daily paid
Work experience placement
Shift work
Hartford HealthCare at Home
Bridgeport, CT
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!