CSV Engineer

1 week ago

Waterford, Waterford, Ireland itContracting Full time

Overview

The Role
The CSV Engineer has a key role in ensuring the ongoing validation compliance of computerised equipment and systems in sterile products manufacturing.

Job Responsibilities

Integrally involved in the validation of all new computerised equipment, and control systemsGenerates validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerised 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 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 sterilisation.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 controlsEnsure compliance to cGMP at all times

Qualifications

Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec)Post-graduate studies as appropriate to augment primary Degree

Experience

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 environmentProject management experience.

Skills and Knowledge

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 regulationsAble to execute projects to plan.Good knowledge of quality management systems.Effective facilitator.Good communication skills at organisation, team and individual levels.Understands KPI's for the site.

EET

If you would like to discuss this role in confidence, contact Harleen Tora/

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