Computer System Validation Specialist

4 weeks ago


Cork, Cork, Ireland International Flavors & Fragrances Full time

Social network you want to login/join with:

Computer System Validation Specialist, Cork

col-narrow-left

Client:

International Flavors & Fragrances

Location:

Cork, Ireland

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Reference:

224f91acc991

Job Views:

4

Posted:

15.06.2025

Expiry Date:

30.07.2025

col-wide

Job Description:

Role Overview

The Computer System Validation (CSV) Specialist helps to ensure IFF Pharma Solution's compliance with company policies, procedures, and industry guidance. The CSV Specialist will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions. This role will be based remotely.

Job Requirements

Responsibilities:


• Coordinate with a multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems.

• Initiate/update GxP and Risk Assessments of computerized systems.

• Create and modify validation documentation including but not limited to criticality assessments, validation plans, user requirement specifications, functional and design specifications, traceability matrices, and CSV protocols (IQ, OQ, PQ).

• Write reports which summarize the results of the protocol executions.

• Write exception reports which identify defects or issues during test execution.

• Manage all aspects of CSV activities for out of the box, configured (GAMP 5 category 4 and custom software (GAMP 5 Category 5) as they relate to the software development life cycle.

• Review vendor documentation.

• Review previously executed CSV work to determine if any gaps exist.

• Qualify vendors of computerized systems

• Draft/Review/Revise CSV SOPs

• Perform other duties as assigned.

• Author System Release Memos and Validation Summary Reports.

• Build data flows for computer validation, establish data chain of custody, in support of both manufacturing and laboratory operations.

• Conduct Audit Trails and Periodic Review of Computer and Automation systems.

Key Qualifications


• Bachelor's degree required, preferred in computer science, engineering, or other sciences.

• Minimum of 2-3 years of experience working with automation and/or computerized system validations.

• Must have direct experience in validation of computer/automation/software validation (prepare IQ, OQ, PQ protocol, resolve deviations, prepare final summary report) in compliance with FDA 21 CFR Part 11 / 210 / 211.

• Strong written and oral communication skills.

• Strong organizational and time management skills.

• Ability to work in cross-functional teams with focus on deliverables, timelines, and meeting expectations and requirements.

• Experience working in a GXP environment.
Preferred Experience:

• Experience working with EudraLex Volume 4 Part I, II and Annex 11, GAMP 5, and MHRA and WHO Guidance on Data Integrity.

At IFF we believe that your uniqueness unleashes our potential. We value the diverse mosaic of the ethnicity, national origin, race, age, sex or veteran status. We strive for inclusive workplace that allows each of our colleagues to bring their authentic self to work regardless of their religion, gender identity & expression, sexual orientation, or disability.

#J-18808-Ljbffr

  • Cork, Cork, Ireland beBeeQuality Full time

    Job Title: Senior Quality Associate for Computer Systems ValidationA global biotechnology company in Limerick is seeking a skilled professional to join their team as a Senior Quality Associate for Computer Systems Validation. This role will be based in a state-of-the-art manufacturing facility and will play a critical part in ensuring the quality and...


  • Cork, Cork, Ireland beBeeValidation Full time

    System Validation RoleThis is a freelance/interim full-time contract position requiring 3 days per week onsite / 2 remote as part of a capital projects team supporting GxP computerized systems.The ideal candidate will have strong knowledge of GxP systems, regulatory expectations, and validation lifecycle practices. Experience delivering complete validation...


  • Cork, Cork, Ireland Catalyx Full time

    Catalyx is seeking an IT Validation Specialist join our team and work on our customer site in Cork. Who We Are: Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes-globally-with a sophisticated blend of...


  • Cork, Cork, Ireland Catalyx Full time

    Catalyx is seeking an IT Validation Specialist join our team and work on our customer site in Cork.Who We Are: Catalyx specializes in the science of operational processes.With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes-globally-with a sophisticated blend of...


  • Cork, Cork, Ireland Independent Solutions Full time

    2 days ago Be among the first 25 applicantsDirect message the job poster from Independent SolutionsSenior Talent Acquisition Specialist at Independent Solution | Hiring for Pharma & Biotech | Expert in Global SourcingJob Opportunity – CSv & Laboratory IT Analyst (Contract)Location: Limerick, Ireland (On-site)Contract Type: 12-month (extendable)Start Date:...


  • Cork, Cork, Ireland beBeeQuality Full time

    Quality Assurance Specialist - Computer SystemsAre you looking for a challenging role in quality assurance within a biotechnology or pharmaceutical company? We are seeking a Quality Assurance Specialist - Computer Systems to join our team. As a Quality Assurance Specialist - Computer Systems, you will play a critical role in maintaining the quality and...


  • Cork, Cork, Ireland beBeeSupport Full time

    IT Support RoleWe are seeking a skilled IT support specialist to join our team. This role involves providing technical assistance and resolving issues related to computer hardware, software, and operating systems. As an IT support engineer, you will be responsible for installing and configuring hardware and software, troubleshooting system problems, and...


  • Cork, Cork, Ireland beBeeValidation Full time

    Job Description:A Process Validation Specialist is required to design, execute and report on PV/Process Performance Qualifications. This specialist will also be responsible for designing, executing and reporting on validation studies for equipment, systems and processes.Key Responsibilities:Designing, executing and reporting on PV/Process Performance...


  • Cork, Cork, Ireland beBeeValidation Full time

    Job Title: Data Validation SpecialistAbout the Role:">">">">We are seeking a skilled Data Validation Specialist to join our team and support the advancement of customer operations.">">The ideal candidate will lead and execute the full lifecycle of qualification activities for process control and packaging serialization systems.">You will be responsible for...


  • Cork, Cork, Ireland Qualcomm Full time

    Company:QT Technologies Ireland LimitedJob Area:Engineering Group, Engineering Group > ASICS EngineeringGeneral Summary: About The Role The System Hardware Validation Engineer will work as part of Qualcomm's SVE (System Validation Emulation) Team on leading technologies such as the Qualcomm Snapdragon chipset.SVE have a critical impact on getting high...