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Validation Engineer

Expired
  • Salary: Negotiable
  • Job type: Contract
  • Location: Waterford
  • Sector: Other
  • Date posted: 30/08/2017
  • Job reference: J333955A

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Validation Engineer (Projects)

Validation Engineer (Projects) required to join a leading biopharmaceutical company on a temporary contact for a new Pre- Filled Syringe project, to ensure that facilities, equipment, systems and processes are validated in accordance with cGMPs.

Responsibilities:

  • Deliver the validation strategy in a safe, compliant manner and to a high standard of performance.
  • Planning, execution and reporting the validation activities of facilities, equipment, systems and processes for Sanofi Waterford.
  • Right first time execution of validation activities and to scheduled timeline
  • Generation & maintenance of validation project plan(s).
  • Generation, review & approval of appropriate validation lifecycle deliverables.
  • Provide validation expertise, technical support and knowledge to site cross functional teams.
  • Assessment, review and approval of project and site change controls and protocol non-conformances.
  • Generation, review and approval of validation & project risk assessments as appropriate.
  • Lead/support validation investigations as appropriate using root cause analysis methodologies.
  • Actively participate in a positive project team environment where support, challenge, empowerment and continuous learning/knowledge exchange is encouraged.
  • Preparation and maintenance of functional project metrics to internal and external stakeholders
  • Proactive participation & validation representation at key site meetings, PAI readiness and regulatory inspections as appropriate
  • Ensure timely closure of Deviations, Events, CAPAs, change controls & Tasks etc
  • Implement continuous improvement initiatives within validation

Qualifications/Experience

  • Degree in Science, Engineering or related area
  • 3-4 years experience working in a Pharma/Biopharma/Med Device/Healthcare manufacturing environment.

Skills & Knowledge

  • Competent technical knowledge of facility/utility/equipment/process/cleaning/computer systems validation for solid oral dosage and sterile manufacturing facilities.
  • Capable of troubleshooting validation issues associated with projects, process development etc.
  • Application of risk-based approach to validation
  • Knowledge and ability to provide interpretation and guidance on industry and regulatory requirements
  • Understanding of relevant quality and compliance regulations
  • Effective project management skills.
  • Detailed knowledge of quality management systems.
  • Good communication skills at organisation, team and individual levels.
  • Ability to use MS Project and SPC packages an advantage
  • Understands KPI's for the team and the site.

For more information on this role contact Paul on 01 6455250 or email

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