1. Job Title : Sr.Functional Analyst (ISG) 2. Job Summary : The Lab Computer System Validation Engineer will be responsible for the validation of Lab Systems in QCL Labs and Manufacturing Operations. We are seeking an enthusiastic and experienced Lab CSV Engineer to join our team. The Lab CSV Engineer will provide systems validation and compliance expertise for newly purchased instruments and support of existing instruments. The position will work within a collaborative Computerised Instruments team and will be required to have excellent communication/i 3. Experience : 6 - 8 years 4. Required Skills : Technical Skills: Empower other Lab systems Labware any LIMS CSV Domain Skills: 5. Nice to have skills : Domain Skills:Manufacturing and Supply Chain 6. Technology : Custom Service 7. Shift : Day 8. Responsibilities : Minimum 3 years experience supporting and validating lab equipment updating documentation system testing troubleshooting Experience of analyzing and challenging s/w to identify gaps. Knowledge of 21CFR Part 11 requirements ER/ES and data integrity guidelines is desirable Strong oral and written communication skills are required with proven ability to communicate and build relationships cross-functionally Self-motivated detail-oriented and excellent organizational and time management skills Capable of relating well to other people with whom s/he comes in contact both within and outside of the laboratory area Manage lab equipment validation projects from software install to business release Prioritize CSV activities in line with the project schedule and monitor budgets Generate computer system validation documentation e.g. Design Spec Configuration Spec Testing Security Plan Test Summary Report in accordance with site procedures and GMP guidelines Review of software release notes Liaise with service providers to determine successful installation of instrument software and ensure correct configuration Determine any specific configurations for the software e.g. how data is saved and named Understand and define user permissions Execute test scripts analyse test results and determine the acceptability of results against pre-determined criteria Work with the business to identify and implement procedural controls to mitigate issues found during testing Initiate and implement Change Control activities in accordance with Quality Standards and Practices Determine solutions or recommendations for changes and/or improvements Produce documentation that is well written and consistent throughout the document body e.g. headings font type font size paragraph spacing text alignment correct tense Follow all relevant Environmental Health and Safety procedures and assist in incident investigations as required 9. Job Location : Primary Location :IECRCORC01(ITIRL Cork - CR IRL CLT/RMT) Alternate Location :NA NA Alternate Location 1 :NA NA 10. Job Type : Sr.Functional Analyst (ISG) [60SG00] 11. Demand Requires Travel? : No 12. Certifications Required : NA
What we offer
- The chance to work with impact. Here, you’re empowered to bring your biggest thinking to help our company and clients improve everyday life.
- Ownership over your career. Stay at the top of your game through our award-winning learning and development ecosystem. And when your ambitions change or we offer new opportunities, we help you pivot by providing reskilling, on-the-job learning and guidance to find new roles that might be a better fit.
- The opportunity to thrive on a high caliber team with heart. We celebrate each other’s experiences and perspectives and promote a sense of belonging through our affinity groups and diversity and inclusion initiatives.
- A comprehensive total rewards package, including a competitive salary and a pension plan with matching contributions.
- Flexible health and financial benefits to support you and your eligible dependents—from day one.
- True work-life balance. Be at your best through paid time off, flexible work arrangements, volunteering opportunities, social events, and so much more.
About us
Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, building the bridge between AI investment and enterprise value by building full-stack AI solutions for our clients. Our deep industry, process and engineering expertise enables us to build an organization’s unique context into technology systems that amplify human potential, realize tangible returns and keep global enterprises ahead in a fast-changing world. See how at www.cognizant.com or @cognizant.
Other employment-related information
Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, provincial or local laws.
If you have a disability that requires reasonable accommodation to search for a job opening or submit an application, please email [email protected] with your request and contact information.
Language requirements vary depending on roles, but we ask that all candidates have basic English proficiency for company-wide communications purposes. For roles based in Quebec, professional English proficiency is required, as you’ll deliver services to and collaborate with stakeholders outside the province who may not speak French.
