CSV Engineer

2 weeks ago

Dublin, Dublin City, Ireland PE Global Full time
Overview

PE Global is currently recruiting for a CSV Engineer for a leading multi-national Biotech client based in Dublin. This is an initial 12-month contract position.



Base pay range

Direct message the job poster from PE Global



Responsibilities
  • Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.
  • Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.
  • Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
  • Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.
  • Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.
  • Participate in change control processes, assessing the impact of system changes and ensuring appropriate validation activities are performed.
  • Provide guidance and support to project teams regarding CSV principles, best practices, and regulatory expectations.
  • Stay updated with industry trends, regulatory changes, and advancements in computer system validation practices.
  • Collaborate with vendors and suppliers to ensure compliance with validation requirements for third-party systems.
  • Support regulatory inspections and audits by providing documentation and participating in direct audit discussions related to computer system validation.
  • Qualification of manufacturing automation systems (i.e DeltaV, MES etc.).


Qualifications
  • Bachelor's degree in Computer Science, Engineering, or a related field.
  • Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • 5+ years experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.
  • Familiarity with validation methodologies, including risk-based validation approaches.
  • Proficiency in creating and executing validation protocols and documenting validation activities.
  • Excellent analytical and problem-solving skills, with attention to detail.
  • Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
  • Ability to work independently and manage multiple projects simultaneously.
  • Knowledge of software development life cycle (SDLC) and change control processes.
  • Understanding of data integrity principles and practices.
  • Experience on sterile drug product manufacturing and associated equipment/utilities/laboratory instruments/IT infrastructure and enterprise systems.
  • Experienced in computer systems validation (CSV) from requirements to through release of SCADA/PLC controlled equipment (e.g., filling lines, isolators, Lyophilisers).
  • Experienced in computer systems validation (CSV) of Emerson DeltaV.
  • Completion of Electronic Records and Electronic Signatures (ERES) assessments and Data Integrity Risk Assessments for equipment/utility systems.
  • Experienced in the use of paperless validation and test tools such as ValGenesis, Kneat, ALM.


Seniority level
  • Mid-Senior level


Employment type
  • Contract


Industries
  • Pharmaceutical Manufacturing
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