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Senior Computer System Validation Csv Jobs in Alabama

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

KBR, Inc.

Senior Computer Scientist

Huntsville, AL · On-site

Senior Computer Scientist Program Summary KBR's Missile, Aviation, and Ground Systems (MAGS) division delivers mission engineering solutions for critical U.S. Army programs, specializing in aviation ...

KBR

Senior Computer Scientist

Huntsville, AL

Senior Computer Scientist Program Summary KBR's Missile, Aviation, and Ground Systems (MAGS) division delivers mission engineering solutions for critical U.S. Army programs, specializing in aviation ...

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Senior Computer System Validation Csv information

What is the difference between Senior Computer System Validation Csv vs Computer System Validation Specialist?

AspectSenior Computer System Validation CsvComputer System Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRegulated industries like pharma, biotech, medical devicesRegulated industries like pharma, biotech, medical devices
ResponsibilitiesLeading validation projects, ensuring compliance, mentoringExecuting validation activities, documentation, testing

While both roles require similar certifications and work in regulated environments, the Senior Computer System Validation Csv typically involves leading projects and overseeing compliance efforts, whereas the Computer System Validation Specialist focuses on executing validation tasks and documentation. The senior role often requires more experience and leadership responsibilities.

What are the key skills and qualifications needed to thrive as a Senior Computer System Validation (CSV) professional, and why are they important?

To excel as a Senior Computer System Validation (CSV) professional, you need deep knowledge of regulatory compliance (such as FDA 21 CFR Part 11), validation lifecycle methodologies, and a background in computer science, engineering, or life sciences. Familiarity with validation management tools, risk assessment software, and quality management systems (QMS) is typically required, along with certifications like GAMP or Six Sigma being highly valued. Outstanding analytical skills, attention to detail, and strong communication abilities set high performers apart in this role. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support quality operations in regulated industries.

What are some common challenges Senior Computer System Validation (CSV) professionals face when working on large-scale projects?

Senior CSV professionals often encounter challenges such as coordinating validation activities across multiple departments, managing evolving regulatory requirements, and ensuring thorough documentation throughout the project lifecycle. They also need to balance project timelines with the need for comprehensive testing and risk assessments. Effective communication and collaboration with IT, QA, and business stakeholders are essential to address issues proactively and ensure compliance in complex, regulated environments.

What is a Senior Computer System Validation (CSV) specialist?

A Senior Computer System Validation (CSV) specialist is an experienced professional responsible for ensuring that computer systems used in regulated industries—such as pharmaceuticals, biotechnology, or medical devices—meet compliance standards. This involves planning, executing, and documenting validation activities to demonstrate that systems consistently perform according to predefined specifications and regulatory requirements. Senior CSV specialists often lead validation projects, manage teams, and interact with regulatory auditors, making sure that systems are reliable, secure, and compliant with guidelines like FDA 21 CFR Part 11 and GxP. Their expertise helps organizations avoid compliance issues, data integrity problems, and costly system failures.
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Senior Computer System Validation Csv jobs near you
Infographic showing various Senior Computer System Validation Csv job openings in Alabama as of July 2026, with employment types broken down into 1% As Needed, 81% Full Time, 15% Part Time, and 3% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution.
Validation Engineer (Aseptic C&Q )

Validation Engineer (Aseptic C&Q )

Centstone

Birmingham, AL • On-site

Contractor

Posted 19 days ago

Job description

Job Title: Validation Engineer (Aseptic C&Q )
Openings: 1
Location: Birmingham, AL (Onsite)
Start: January 2026
Duration: Minimum 6 months (extendable)
Employment Type: Contract

Job Summary
We are seeking a Validation Engineer with strong experience in aseptic pharmaceutical validation and equipment qualification. The ideal candidate will have hands-on expertise in C&Q activities, documentation, and compliance aligned with FDA/EU/GMP standards. This role will support new and existing aseptic facilities and critical manufacturing systems.

Key Responsibilities

  • Develop and maintain validation/qualification documentation for aseptic facilities and equipment.

  • Create and execute C&Q deliverables including URS, risk assessments, commissioning plans, IQ/OQ/PQ protocols, and final reports.

  • Perform Commissioning (COM), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.

  • Ensure all validation documentation meets internal quality standards and regulatory expectations (FDA/EU/GMP).

  • Conduct risk assessments and define mitigation strategies for aseptic processes and systems.

  • Collaborate cross-functionally with Engineering, Quality, Manufacturing, and other stakeholders to meet project timelines.

  • Support requalification and lifecycle management activities for validated systems and equipment.

  • Lead or support Computer System Validation (CSV) activities, including system classification, test script creation/execution, and compliance reporting.

  • Verify system functionality and data integrity consistent with regulatory requirements.

Required Qualifications

  • Bachelor’s degree in Engineering or Science (preferred).

  • 3–5 years of experience in validation/qualification of aseptic pharmaceutical processes and/or equipment.

  • Strong knowledge of FDA/EU regulatory frameworks, GMPs, and industry best practices.

  • Demonstrated experience authoring and executing URS, protocols, and validation reports.

  • Strong understanding of pharmaceutical manufacturing equipment and process validation.

  • Proficiency with documentation tools and Microsoft Office (Word, Excel, PowerPoint).

  • Excellent communication, organization, and stakeholder management skills.

  • Ability to work independently and within cross-functional teams.

Preferred/Tools & Equipment Exposure

  • Experience with Kaye Validator AVS and ValProbe systems.

  • Knowledge of qualification for equipment such as:

    • Homogenizers

    • Pump skids

    • SIP/CIP skids

    • Temperature control units (CTUs)

    • Tanks and related utilities

  • Experience supporting aseptic facility start-ups, expansions, or technology transfers.

Thanks & Regards,

Adarsh Mallik | IT Recruiter
adarsh.mallik@centstone.com
CENTSTONE SERVICES
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About Centstone

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In the dynamic landscape of today’s business environment, flexibility is key. At Centstone, we understand the unique demands of your industry and offer tailored Contract Hiring solutions to empower your organization with the right talent when you need it most.

Industry

Recruiting and staffing services

Company size

51 - 200 Employees

Headquarters location

Hazlet, NJ, US

Year founded

2022

Social media

Facebook

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