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Director Computer System Validation Csv Jobs in Alabama

Senior Project Engineer MEP

Huntsville, AL

$97K - $127K/yr

Provides dedicated owner-side oversight of all automation, control systems, and digital integration scope encompassing DCS/PLC, BAS, SCADA, MES, LIMS, and Computer System Validation (CSV) under GAMP5 ...

New

... computer system validation, spreadsheets, test method validation and process validation. * Writes and/or revises IQ, OQ, PQ related documents, including any or all of the following: SOP's, validation ...

Support development of coding, testing, debugging, and system validation requirements . Liaise with ... Click here to be directed to our site that is dedicated to veterans and transitioning service ...

You will own system-level validation of the complete Neptune solution - meters, gateways ... Bachelor's degree in Engineering, Computer Science, or related field required; Master's degree a ...

Computer User Support Specialist

Creola, AL · On-site

$14.88 - $24.88/hr

Recommend system and process modifications to reduce recurring user problems. Maintains current ... Possession of a valid driver's license. * Availability to work a standard Monday-Friday schedule ...

Computer User Support Specialist

Creola, AL · On-site

$14.88 - $24.88/hr

Recommend system and process modifications to reduce recurring user problems. Maintains current ... Possession of a valid driver's license. * Availability to work a standard Monday-Friday schedule ...

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Director Computer System Validation Csv information

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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

Sourced by ZipRecruiter

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

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