Lab CSV Engineer

Job Category:
Software Developer/Engineer
Job Type:
Permanent
Level of IT Experience:
5-10 Years
Area:
Central Dublin
Location:
Dublin
Salary Description:
Competitive salary offered
Posted:
10/08/2022
Recruiter:
Confidential
Job Ref:
1670244433

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

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Contact Details:
Confidential
Contact: Contact

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