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Computer System Validation Csv Pharmaceutical Jobs in Alabama

Southern Research

Senior Validation Analyst

Birmingham, AL

$108K - $109K/yr

Advanced knowledge of pharmaceutical/CRO industry regulations, standards, and guidelines (GxP, CSV ... Strong attention to detail and the ability to learn new computer systems with minimum instruction.

Southern Research

Senior Validation Analyst

Birmingham, AL · On-site

$110 - $140/hr

Advanced knowledge of pharmaceutical/CRO industry regulations, standards, and guidelines (GxP, CSV ... Strong attention to detail and the ability to learn new computer systems with minimum instruction.

NEOGOV

Computer System Administrator

Huntsville, AL · On-site

Job Summary : NEOGOV is part of the Madison County Commission, seeking a Computer System ... Must have a valid Driver's license and be insurable by the Madison County Commission's risk ...

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Computer System Validation Csv Pharmaceutical information

What is computer system validation (CSV) in the pharmaceutical industry?

Computer System Validation (CSV) in the pharmaceutical industry is a process used to ensure that computerized systems used in drug manufacturing and related processes work as intended and comply with regulatory standards, such as FDA 21 CFR Part 11. CSV involves planning, testing, documenting, and maintaining systems to guarantee the accuracy, reliability, and integrity of data. This is critical for patient safety and product quality, as well as for meeting legal and regulatory requirements. The process typically includes risk assessment, validation planning, protocol execution, and ongoing monitoring of system performance.

What are common challenges faced by computer system validation (CSV) professionals in the pharmaceutical industry?

CSV professionals in the pharmaceutical industry often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring thorough validation of complex systems within tight project timelines. Collaboration with cross-functional teams, such as IT, quality assurance, and manufacturing, is essential to address technical and compliance issues. Additionally, balancing the need for robust validation with operational efficiency requires strong communication and project management skills.

What are the key skills and qualifications needed to thrive as a computer system validation (CSV) professional in the pharmaceutical industry?

To thrive as a Computer System Validation (CSV) professional in pharmaceuticals, you need a strong background in life sciences or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience with validation protocols. Familiarity with validation lifecycle management tools, quality management systems (QMS), and industry guidelines like GAMP 5 is typically required, along with certifications such as ISPE or PMP being advantageous. Outstanding attention to detail, analytical thinking, and strong communication skills help ensure compliance and effective coordination with cross-functional teams. These competencies are vital for maintaining regulatory compliance, data integrity, and patient safety in pharmaceutical operations.

What is the difference between Computer System Validation Csv Pharmaceutical vs Quality Assurance Specialist?

AspectComputer System Validation Csv PharmaceuticalQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, Validation certificationsGxP, ISO, QA certifications
Work EnvironmentPharmaceutical manufacturing, regulated labsQuality departments across industries, including pharma
Employer & IndustryPharmaceutical companies, biotech firmsPharma, biotech, healthcare organizations
Primary FocusEnsuring computer systems meet validation and compliance standardsMaintaining quality standards and process improvements

Computer System Validation Csv Pharmaceutical specialists focus on validating computer systems to ensure compliance with industry regulations, while Quality Assurance Specialists oversee overall quality processes. Both roles require GxP knowledge and are vital in pharmaceutical environments, but their core responsibilities differ in scope and focus.

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For Computer System Validation Csv Pharmaceutical jobs in Alabama, the most frequently searched job titles are:

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The top searched job categories for Computer System Validation Csv Pharmaceutical jobs in Alabama are:

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Cities in Alabama with the most Computer System Validation Csv Pharmaceutical job openings:

Computer System Validation Csv Pharmaceutical jobs near you

Validation Engineer (Aseptic C&Q )

Centstone

Birmingham, AL • On-site

Contractor

Re-posted 13 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

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