Validation Engineer (contract) - Dublin

Lawrence Harvey

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Job ID :

8247


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Other


Address 1 :

Western Europe,--Dublin,Dublin,


Key Skills :

Validation, engineer, dublin, ireland


Salary :

Negotiable


Date Posted :

10 Aug, 2017



Company Name :

Lawrence Harvey


Location1 :

Dublin




Job Category :

Quality Assurance Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

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.



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 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).


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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