Company Profile:
12-month contract opportunity for a Junior CSV Engineer to join an employer who is consistently ranked as one of Irelands top workplaces that fosters collaborative and inclusive environment. If you have a background in writing validation protocols, reports, compliance documentation and are looking to get more practical knowledge in Computer Systems Validation this could be for you as it would be supporting site-wide operations.
Key Responsibilities:
• Integrally involved in the validation of all new computerized equipment, and control systems at Sanofi Ireland Ltd.
• Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerized equipment and systems.
• Participates in the change control process advising on CSV issues, as appropriate
Compliance Related Tasks
• Hands on role in the development and execution of DQ, IQ, OQ and PQ activities.
• Ensures projects are managed in compliance with all required Sanofi and legal requirements (Health & Safety, cGMP, construction, environmental etc).
• Designs, implements and executes validation studies for manufacturing and control equipment. Additional responsibilities for critical systems and facilities as well as validation studies to satisfy regulatory compliance.
• Provide technical assistance on current US FDA and EU validation requirements for lyophilization, aseptic processing and sterilization.
• Ensure that the validation status of equipment and systems are in compliance with cGMP at all times.
• Maintain validation documentation through the
• Approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans
• Generate/review/approve execution of the validation/revalidation plans
• Review and approval of site change controls
• Ensure compliance to cGMP at all times
Key Skills, Experience & Qualifications:
• Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec)
• Post-graduate studies as appropriate to augment primary Degree
• 3-5 years experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
• 2-3 years experience in validation environment
• Project management experience.
• Capable of troubleshooting validation issues associated with projects, process development etc.
• Competent technical knowledge of pharmaceutical plants.
• Knowledge of requirements for of GAMP, ISPE Baseline guides.
• Full understanding of relevant quality and compliance regulations
• Able to execute projects to plan.
• Good knowledge of quality management systems.
• Good communication skills at organization, team and individual levels.
• Understands KPI’s for the site.
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