CSV Lab Engineer
PE Global requires a CSV Lab Engineer for one of our clients in Cork, this position will be for 6 months initially. Role Summary Reporting to the relevant IM Manager/Lead, this position will have a significant role in the validation of computerized systems within the QC laboratory at the Shanbally facility. The person will participate in the development of custom programs, as well as configurable off the shelf (COTS) systems. Duties include ongoing evaluation and periodic review of existing validated computer systems; change control. Other responsibilities of this position include: generation and execution of validation deliverables and SDLC documents for new systems within the laboratories. Role Responsibilities Vector Gene Therapy Laboratory Implementation: Develops and executes all validation deliverables for new systems (e.g. qPCR, Platereaders, HIAC, UV-Vis, HPLC, SoloVP, CE PA800, etc) within the Gene Therapy lab. Capable of owning issues/deviations and driving them to resolution. Capable leading testing efforts for small to medium sized projects. 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. Other duties as assigned. Responsible for assessing the validation impact of changes made to the qualified instruments. Education Required Minimum of a Computer Science or Engineering/Science Degree. Proficiency with minimum 5+ years’ experience in 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. 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 qualifying QC Laboratory instruments. Proficiency with MS Office applications (Word, Excel, Visio, Access, Project, Power Point. Experience with HP ALM or equivalent software testing/requirements tools. 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.
70 days ago