Lab CSV Engineer

Dublin site based

Zenith Technologies, now a Cognizant Company 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, Zenith partners with the leading Life Sciences companies globally to provide performance improvements, reduced costs and improve time to market.

About the Role:

The Lab Systems Engineer will work with a team onsite with our client in Dublin and be responsible for the validation of PC Controlled Analytical Laboratory Systems for their facility. The candidate will need to have experience in validation and support of Laboratory systems/IT applications. The candidate is expected to be self-motivated and develop an understanding of the business. Experience of working in a pharmaceutical manufacturing operation is desirable.

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

Requirements

Requirements:

· 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