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 a dedicated, innovative and driven LabTech IT Senior Engineer to join our expanding team in Dublin.
Responsibilities:
- Manage lab equipment validation projects from PC built/Images to software install to supporting all IT activities for system release.
- Proactively identify risks and issues developing strategies to mitigate them and ensuring transparent communication with stakeholders.
- Generate IT validation documentation e.g. IT Infrastructure Design Spec Configuration Spec Risk Assessments Security Plan and Administration SOPs 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.
- Managed Active Directory maintaining user accounts groups and permissions for secure access.
- Preparation and Configuration of Backup and Restoration process for laboratory Softwares.
- Assist where required for executing test scripts analyze 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.
- Investigate incidents perform root cause analysis and resolve Lab workstation IT-related issues.
- Manage Change Validation Discrepancy/Deviation and CAPAs related to LabTech activities.
- 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.
Candidate Requirements:
- Bachelor’s degree in computer science information technology or a related field PMP RTE or equivalent certification preferred.
- 5+ years of experience in IT validation engineer role with a focus on laboratory systems in the Pharmaceutical Biopharma and healthcare Industry.
- IT experience supporting and validating lab equipment updating documentation system testing troubleshooting with experiences in IT Infrastructure Network and Server configuration NTFS permissions Network shares and secure desktop is desirable.
- Knowledge of regulatory guidelines such as FDA 21 CFR Part 11 EU Annex 11 Data Integrity and GAMP 5 is desirable.
- Strong oral and written communication skills are required with proven ability to communicate and build relationships cross-functionally.
- Strong understanding of laboratory operations workflows data management and regulatory compliance.
- Strong analytical and problem-solving skills with a track record of managing multiple projects simultaneously.
- Self-motivated, detail-oriented and excellent organizational and time management skills.
- Capable of relating well to other people with whom they come in contact both within and outside of the laboratory area.
To apply for this inclusive and collaborative full-time LabTech IT Senior Engineer role , don't hesitate to contact Cognizant today.
At Cognizant, we engineer modern businesses to improve everyday life because we're dedicated to making a lasting impact. Cognizant (Nasdaq: CTSH) engineers’ modern businesses. We help our clients modernize technology, reimagine processes and transform experiences so they can stay ahead in our fast-changing world. Together, we're improving everyday life.
コグニザントのコミュニティ
コグニザントは、クライアントのビジネス、運営、技術モデルをデジタル時代に合わせて変革する、世界有数のプロフェッショナルサービス企業の一つです。私たちの独自の業界ベースのコンサルティングアプローチは、クライアントがより革新的で効率的なビジネスを構想し、構築し、運営するのを支援します。米国に本社を置くコグニザント（NASDAQ-100のメンバーであり、Forbesの2024年世界最高の雇用者の一つ）は、常に世界で最も称賛される企業の一つに挙げられています。コグニザントがどのようにしてクライアントがデジタルでリードするのを支援しているかについては、www.cognizant.comをご覧ください。
- コグニザントは世界中に300,000+上の社員を擁するグローバルな会社会社です。
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- キャリアを築いていくことができる革新的な環境を育んでいきます。
コグニザントについて
コグニザント（Nasdaq-100: CTSH）は世界有数のプロフェッショナル・サービス企業であり、企業がテクノロジーの近代化、プロセスの再構築、エクスペリエンスの変革を実現し、変化の激しい世界で優位に立てるよう支援しています。
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