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Validation Engineer

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Dublin
  • Sector: Other
  • Date posted: 30/08/2017
  • Job reference: J369996A

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Validation Engineer

Validation Engineer required to join a leading biotech company in Dublin on a permanent basis.

Initially part of a project team to perform Commissioning, Qualification and Validation (CQV) to complete execution and start-up of a new project. After project completion this position will transition to continue CQV activities and change control in support of the ongoing operations of the plant.

Responsibilities:

  • Responsible for validating, at a minimum, the SIP of vessels, including Bioreactors and varying sizes of fixed vessels.
  • Assist in the development of system/equipment matrices/bracketing approaches to streamline the validation approach.
  • Coordinating and monitoring the validation/project phases and informing management of project progress.
  • Creating and executing protocol test scripts in accordance with cGMP, regulatory requirements, the Computer System Validation Master/Project Plan, and Policies, Procedures & Guidelines to ensure robust tested systems, which are fit for use.
  • Assisting in audit preparation and presentation of the above systems for internal, vendor and regulatory audits.
  • Providing regulatory guidance and support in the management of system upgrades, changes and general validation challenges, and providing support in identifying the need for creation/updating operating procedures or templates.
  • Liaising with suppliers and conducting Factory Acceptance and Site Acceptance tests where applicable.
  • Responsible for review of all design deliverables from the Engineer including drawings, datasheets, specifications and engineering lists.
  • Point validation person for review for all associated vendor packages.
  • Liaise with CQV start-up team in relation to punch list closure both pre-mechanical completion and during the CQV execution phase.
  • Ensure commissioning readiness of all systems to support equipment start-up and IOQ testing.
  • Support execution of all CQV deliverables; FAT/SAT/CTP/IOQ
  • Generate and ensure timely approval of all Commissioning and IOQ Final Reports for systems.

Qualifications

  • BSc qualification (Degree) in a scientific, technical or engineering discipline
  • 2+ years of experience within the pharmaceutical industry.
  • A Strong background in validation and biologics manufacturing is desired.
  • Knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, Q9)
  • Problem solving ability and excellent oral and written communications skills
  • Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)

For more information contact Paul on 016455250 or email

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