Cache of job #13963801

Job Title

CSV (Computer Systems Validation) Mes E

Employer

Pe Global

Location

Cork

Description

PE Global requires a CSV MES Engineer for one of our clients in Cork, this position will be for 6 months initially Role Summary This position will have a significant role in the qualification / implementation of MES at the facility. Primarily this person will be mainly responsible and accountable for the site MES implementation (PAS-X) in the areas of systems requirements, configuration, test execution, release for use and ongoing change management efforts. Role Responsibilities Work closely with the Business Analyst to understand and ensure MES User Requirements are clear, concise and deliverable. Responsible for generation and execution of the MES Application Lifecycle Management documentation. Capable of owning issues/deviations and driving them to resolution. Plan and perform system integration testing, end to end testing and UAT. Capable of reviewing vendor protocols, test scripts, and traceability matrix. Capable of generating test scripts to meet the user requirements. Interacts directly with project teams and the associated vendors. Responsible for assessing the validation impact and leading testing efforts for small to medium sized changes. Other duties as assigned. Education Required: Minimum of a Computer Science, Business Informations Systems or Engineering/Science Degree with minimum 5+ years’ experience in a Bio-Pharmaceutical or equivalent type life science industry. Skills & Experience Required Good verbal and written communication skills. Good organizational skills. Must have good interpersonal skills. Position will require a good deal of interdepartmental interaction and coordination. Must possess a thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11 / Annex 11 requirements. Must possess a thorough understanding of current industry guidance, including GAMP 5. Must have direct experience with computer validation and determining computer validation approach, including enterprise platforms systems as well as custom software projects. Must have ability to comprehend technical information related to computer software, computer and network hardware, and the associated regulatory requirements relating to them. Experience/Knowledge in OSI PI, DeltaV, MES (PAS-X. Proficiency with MS Office applications (Word, Excel, Visio, Access, Project, Power Point. Experience with HP ALM or equivalent software testing/requirements tools. Supervisory Responsibility This position will have consultants/contractors reporting to it on a project basis. Please send in your CV for the attention of Robert Carroll or contact 021 4520311 for more information. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.

Date Added

1957 days ago

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