Eurofins
Computer Systems Specialist - Eurofins CDMO Alphora, Inc.
About 1 month ago
About the Job
- Primary IT contact / Subject Matter Expert to ensure Laboratory Computerized Systems and Computerized Systems supporting Operations Equipment (i.e. Computerized Systems) are installed, qualified/ validated, and maintained in accordance with in-house procedures and regulatory standards (e.g. cGMP, GAMP 5, 21 CFR part 11) suitable for the equipment’s intended use
- Support the acquisition, configuration and installation of Computerized Systems
- Support the development of Risk Assessments and User for new and modified Computerized Systems
- Obtain vendor specifications for assessment against URS, compliance, Eurofins IT and other integration applications
- Ensure URS and Risk assessment of systems before purchase, work with IT to prepare for approvals with Eurofins
- Support Eurofins IT Form application submissions
- Support the development of Qualification / Validation Protocols and Reports for new and modified Computerized Systems
- Responsible for execution of the IT portion of Computerized Systems Qualification / Validation Protocols, including solving problems and addressing discrepancies identified during execution
- Assist in the development of Standard Operating Procedures related to usage and maintenance of Computerized Systems
- Develop, execute and maintain assigned IT Preventative Maintenance (PM) tasks for Computerized Systems
- Support Laboratory Management with the general maintenance, troubleshooting, and repairs of Laboratory Computerized Systems, including interactions with third-party vendors, as required
- Support Operations Management with general maintenance, troubleshooting, and repairs of Computerized Systems supporting Operations Equipment, including interactions with third-party vendors, as required
- Support the evaluation of proposed changes to Computerized Systems, including the writing and execution of Change Controls, as required
- Support qualification and start-up activities for new Biologics business unit
- Maintain documentation in accordance with Good Documentation Practices
- Training of Staff on the use of equipment as needed.
- Collaborate within IT, other departments (e.g. QA, Engineering, corporate IT), and external vendors
About the Company

Eurofins
<div class="org-about-module__description"> <div id="ember58" class="ember-view organization-about-module__content-consistant-cards-description"><span class="lt-line-clamp__raw-line">Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is a global leader in food, environmental, pharmaceutical and cosmetic product testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. Since 1987, Eurofins has grown from one laboratory in Nantes, France to ca. 62,000 staff across a network of independent companies in 62 countries, operating over 900 laboratories. Performing over 450 million tests every year, Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing. Ever since its IPO on the French stock exchange in 1997, Eurofins has been one of the fastest growing listed European companies.</span></div> </div> <div class="org-about-module__content-improvement"> <div class="org-about-module__content-box"> </div> </div>
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