Validation Engineer (contract) - Dublin
|Job Title:||Validation Engineer (contract) - Dublin|
|Location:||Dublin, Republic of Ireland|
|Contact Name:||Nathan Wilson|
|Job Published:||August 10, 2017 13:05|
Initially part of a project team to perform Commissioning, Qualification and Validation (CQV) to complete execution and start-up of the MPCC project. After project completion this position will transition to continue CQV activities and change control in support of the ongoing operations of the plant.
- 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 and Experience required
- The candidate should hold a minimum of a BSc Qualification in a scientific, technical or engineering discipline along with 2+ years' 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).
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