Top 513 System validation Jobs in Cincinnati, Oh

Instrumentation Software Validation Analyst
Katalyst Healthcares & Life Sciences —Cincinnati, OH
- Contract
- Computer Science
- 5 years
- Laboratory experience
Quick Apply
System Test and Validation Lead
Deloitte —Cincinnati, OH
- $95,000 - $145,000 a year
- Full-time
- Remote
- Computer science
- 6 years
- Computer Science
CSV Analyst with Instrument integration & Validation expertise
Katalyst Healthcares & Life Sciences —Cincinnati, OH
- Contract
- Hybrid work
- Computer Science
- 5 years
- Laboratory experience
Quick Apply
Automation Controls Engineer
Absolute Machine Tools, Inc. —Mason, OH
- $95,000 - $115,000 a year
- Full-time
- Background check
- Mid-level
- Analysis skills
- Health savings account
- Paid holidays
Quick Apply
Senior 401K Retirement Specialist
Western & Southern Financial Group —Cincinnati, OH
- From $70,400 a year
- Full-time
- Research
- Office
- Accounting
- Health insurance
- Dental insurance
Quick Apply
Field Service Engineer
Bonfiglioli Engineering —Harrison, OH
- Full-time
- Mid-level
- 3 years
- Travel
- Health savings account
- Health insurance
Quick Apply
1d
Sr. Technical Writer-OH
Dayton T. Brown, Inc. —Cincinnati, OH
- $35 - $45 an hour
- Full-time
- 7 years
- Research
- Office
- Profit sharing
- Health insurance
Quick Apply
Controls Engineer
Kodiak Labor Solutions —Cincinnati, OH
- $80,000 - $110,000 a year
- Full-time
- Engineering
- System design
- Mid-level
Quick Apply
Compensation Specialist
Baker Construction Enterprises Inc —Monroe, OH
- Microsoft Word
- Microsoft Excel
- Customer service
Senior Electrical Engineer
Quantam Solutions —Highland Heights, KY
- $90,000 - $130,000 a year
- Full-time
- Background check
- 3 years
- Analysis skills
- Health insurance
- Dental insurance
Quick Apply
6d
3rd Shift Quality Control Supervisor - Erlanger, KY
ADM —Erlanger, KY
- $58,100 - $108,000 a year
- Overtime
- Background check
- Mid-level
- Microsoft Office
- Paid parental leave
- Health savings account
Manager, Refrigeration Engineering
Thermo Fisher Scientific —Cincinnati, OH
- Full-time
- Office
- 3 years
- Master's degree
8d
Manager, Electrical Engineering (Embedded Controls)
Thermo Fisher Scientific —Cincinnati, OH
- Full-time
- Office
- Master's degree
- Product management
- Paid holidays
- Health insurance
6d
Process Engineer
The C.W. Zumbiel Company —Hebron, KY
- Full-time
- Mid-level
- US work authorization
- In-person
- Wellness program
- Health insurance
Quick Apply
Fusion Risk Management Consultant
Robert Half —Cincinnati, OH
- Temporary
- Mid-level
- US work authorization
- Disability insurance
- Dental insurance
Quick Apply
7d
Senior Manager, Master Data Management
Procter & Gamble —Cincinnati, OH
- $110,000 - $165,000 a year
- Full-time
- Hybrid work
- Computer Science
- 5 years
- Office
Director of Food Science
Sugar Creek Packing Co. —West Chester, OH
- Full-time
- Microsoft Excel
- Computer literacy
- Master's degree
Quick Apply
Mechatronics Technician
ADVICS Manufacturing Ohio —Lebanon, OH
- Overtime
- Mid-level
- Ability to lift 50 pounds
- Plumbing
- Profit sharing
- Paid holidays
Quick Apply
6d
Data Center Controls Engineer, Data Center Capacity Delivery - Controls
Amazon Data Services, Inc. —Trenton, OH
- $111,300 - $186,100 a year
- Full-time
- 5 years
- Mid-level
- AD&D insurance
- Health insurance
Project Engineer - Sharonville, OH
DuBois Chemicals —Sharonville, OH
- Full-time
- Microsoft Excel
- Schematics
- Continuous improvement

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system validation jobs near cincinnati, oh

Instrumentation Software Validation Analyst

Katalyst Healthcares & Life Sciences -
Cincinnati, OH

Quick Apply

Job Details

Contract

Qualifications

Quality control corrective actions
Data integrity assurance
Regression testing implementation
Process flow diagrams
Feature validation testing
Empower (software)
GAMP
Defect resolution root cause analysis
Computer Science
Requirements specification
Requirements design
Procedural guides
Test Case Documentation (Quality assurance practices)
5 years
Laboratory experience
Laboratory information management systems
FDA 21 CFR Part 11
Mid-level
System design for system development
Data integrity and documentation
Bachelor's degree in engineering
Production validation processes
Change management for system development
Quality risk management
Embedded software
Pharmaceutical company experience
Compliance documentation
Software documentation
Regulatory/legal compliance standards in production
Biomedical regulatory compliance

Full Job Description

Job Summary:

We are seeking an experienced Instrument Software Validation Analyst to support validation and compliance of laboratory, manufacturing, and embedded software systems in regulated environments. The role ensures systems operate reliably and remain in a validated state in accordance with FDA, EMA, and GxP requirements. This position acts as a bridge between technical software validation, testing, and regulatory compliance.

Roles & Responsibilities:

Software Validation & Compliance

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

Documentation & Regulatory Support

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

System Analysis & Design

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

Testing & Execution

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

Risk & Change Management

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

Education & Experience:

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

Quick Apply

Refine Your Search

system validation jobs in cincinnati, oh

Instrumentation Software Validation Analyst

System Test and Validation Lead

CSV Analyst with Instrument integration & Validation expertise

Automation Controls Engineer

Senior 401K Retirement Specialist

Field Service Engineer

Sr. Technical Writer-OH

Controls Engineer

Compensation Specialist

Senior Electrical Engineer

3rd Shift Quality Control Supervisor - Erlanger, KY

Manager, Refrigeration Engineering

Manager, Electrical Engineering (Embedded Controls)

Process Engineer

Fusion Risk Management Consultant

Senior Manager, Master Data Management

Director of Food Science

Mechatronics Technician

Data Center Controls Engineer, Data Center Capacity Delivery - Controls

Project Engineer - Sharonville, OH

I want to receive the latest job alert for system validation in cincinnati, oh

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