Computer Systems Specialist

Eurofins CDMO Alphora is looking for a Computer Systems Specialist to join our IT team to support the installation, qualification/validation and ongoing maintenance of GMP and non-GMP Computerized Systems supporting pharmaceutical and biopharmaceutical product development, manufacture and testing. 

WHO ARE WE?

Eurofins CDMO Alphora Inc. provides a fully integrated suite of services to support drug substance and drug product development from the IND enabling development stage, through to phase II & III supply, and commercial validation and manufacturing for niche APIs.  In addition to a continuing flow of interesting and challenging projects for global pharmaceutical and biotech companies, Eurofins CDMO Alphora Inc. is committed to growing its state-of-the-art organization, with continued investments in its people, modern facilities, equipment, and instrumentation.

Job Description

• 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

Qualifications

• Education: Bachelor’s degree in business/technical area or comparable education/experience. 
• 5-year min experience in Computer Systems Validation within the pharmaceutical / biotechnology GMP environment including authoring and execution of IQ/OQ/PQ’s, experience in performing traceability matrices, risk assessments is preferred
  Must have a collaborative mindset and be a self-starter
• Strong oral/written communication skills
• Strong technical writing abilities required to draft SOPs and PMs
• Strong technical skills in hands-on configuration of a variety of Laboratory systems (ie. Mass Spec, IC, Matersizer, UV, FTIR, DSC etc.)
• An advanced understanding of security of data systems for the protection of electronic assets, intellectual property, and privacy. 
• Experience in developing and implementing complex data exchange technology processes between information systems.
• Experience in creating/developing a moderate to complex functional requirement mapping to an Information System based on business requirements.
• Ability to independently identify compliance risks and escalate when necessary. 

COMPANY DESCRIPTION

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 our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, 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 believes it is a global leader in food, environmental, pharmaceutical and cosmetics products 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.

In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2022, Eurofins generated total revenues of EUR 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years.

Additional information

At Eurofins we offer excellent full-time benefits including health & dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays, paid time off.

As a Eurofins employee, you will become part of a company that has received international recognition as a great place to work. To learn more about Eurofins, please explore our website at www.eurofins.ca

We thank all applicants within commuting distance of GTA, Ontario for showing an interest in this position. Only those selected for an interview will be contacted.