CV-Library
LAB System Engineer
Cognizant is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimized to improve operational efficiencies, whilst maintaining compliance.
Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures and services.
Operating across 5 continents and with over 300.000 skilled employees, Cognizant partners with the leading Life Sciences companies globally to provide performance improvements, reduced costs and improve time to market. We are your single end to end partner for consultancy, design implementation, optimization and support for all applications in the Pharmaceutical and Biotechnology Manufacturing stack.
We're looking for dedicated, innovative and driven talent to join our expanding team.
Location: Dublin, Ireland
Job summary
* Conduct validation activities for Lab systems in accordance with Quality Standards and Practices and
* GMP guidelines.
* Initiate and implement Change Control activities for existing quality systems in accordance with Quality Standards and practices.
* Resolve validation issues incident problems and deviations using data analysis and problem-solving skills.
* Troubleshoot failures on the system and resolve same. Schedule system maintenance. Prioritize validation activities in line with the project schedule.
Roles & Responsibilities
* Conduct validation activities for Lab systems in accordance with Quality Standards and Practices and GMP guidelines. Initiate and implement Change Control activities for existing quality systems in accordance with Quality Standards and practices.
* Resolve validation issues incident problems and deviations using data analysis and problem-solving skills.
* Troubleshoot failures on the system and resolve same. Schedule system maintenance. Prioritize validation activities in line with the project schedule.
* Update existing validation documentation including SOPs Design Specs configuration specs.
* Follow all relevant Environmental Health and Safety procedures and assist in incident investigations as required.
* As a member of the technical team, he/she will be responsible for adhering to and improving where appropriate safety procedures to protect him/her other personnel and company property. Possess the capability of relating well to other people with whom he/she comes in contact both within and outside of the laboratory area. Recognise the importance of the quality control function in pharmaceutical production the IT Validation Engineer should display a high level of integrity in the performance of his/her work.
* Suitability degree qualified IT/ Automation/ or equivalent engineer.
* Minimum 2-4 years experience supporting Lab systems/IT applications e.g. requirements gathering design documentation test case development system & integration testing.
* Minimum 2 years experience in a regulated environment.
* Experience working in a Win 7 environment is an advantage.
* Past proven experience engaging business users to ensure that appropriate business needs are clearly defined communicated and delivered at or above expectations.
* Strong oral and written communication skills are required with proven ability to communicate and build relationships cross-functionally.
* Experience of ER/ES and 21 CFR part 11 compliant software desirable.
Experience – 5 years industry experience
Required Skills – Labvantage LIMS
Nice to have skills – Oracle Labware ELN