Direct message the job poster from PSC Biotech Corporation
Expert Recruiter - Client Services - Delivery Specialist - International Strategic Resourcing - Honest Recruitment
PSC Biotech Corporation is seeking an experienced CSV (Computer System Validation) Consultant for an on-site contract role in Cork. This position requires strong CSV expertise with direct experience in SAP system validation within regulated environments.
About PSC Biotech Corporation
Founded in 1996, PSC Biotech provides world-class support to life science companies across more than 35 countries. Through our three divisions—PSC Biotech, PSC Software, and BioTechnique—we offer consulting, software, contract manufacturing, and metrology services. We are committed to quality, compliance, and delivering excellence across the life sciences.
Role Overview:
As a CSV Consultant, you’ll be responsible for ensuring computer systems—especially SAP and related platforms—are validated in compliance with regulatory standards. This includes developing and executing validation protocols and maintaining system integrity throughout its lifecycle.
Key Responsibilities:
* Conduct risk assessments and develop validation protocols (IQ/OQ/PQ)
* Execute validation activities and prepare comprehensive validation reports
* Lead or support SAP system validation and related project activities
* Collaborate across departments to ensure data integrity and system compliance
Qualifications:
* Proven experience in Computer System Validation (CSV), including SAP modules (e.g., MM, QM, PP, SD, WM, PM)
* Strong understanding of GxP, 21 CFR Part 11, and Annex 11 compliance requirements
* Experience with SAP systems in a regulated life sciences setting
* Excellent documentation and analytical skills
* Effective communicator with cross-functional team collaboration skills
* Bachelor’s degree in Science, Engineering, or related field
* Previous work in a GMP-regulated environment is a plus
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Contract
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing
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