Engineer III Validation (CSV) – Thermo Fisher – MA, USA

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information
Thermo Fisher Scientific, Viral Vector Services (VVS) is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members; are committed to making a difference in our organization, for our client partners and the patients we serve.

How will you make an impact?
The Engineer III, Validation (CSV) will lead all computer system validation projects for the site with collaboration from Global CSV and IT team. Partner with system owners and Quality to develop Validation plans for new systems and support maintenance of qualified systems.

What will you do?

• Author and review all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications, Gap Assessments, Risk Assessments etc
• Responsible for developing and revising test validation procedures/protocols in accordance with appropriate regulatory agency validation requirements, site quality management system, and current industry practices
• In addition, this individual will serve as the SME to provide compliance leadership and oversight for CSV projects
• Collaborate with departments -within the organization to maintain and improve computer system validation processes to ensure robust, efficient, and compliant processes

How will you get here?

BS degree or equivalent in technical area preferred and a minimum of 8 plus years’ experience in the validation of computer systems for manufacturing, equipment and process, as well as utilities, and facilities.

• Experience in the biotechnology and/medical or pharmaceutical industry with strong GDP (Good Documentation Practices) skills
• Proficiency of Computers Systems Validation and Quality Systems.
• Good knowledge and skills in Engineering & Automation for HVAC/ Process Utility/Monitoring Building Management Systems
• Experience with systems such as VMware ESXi, Syncade, OSI PI, Infobatch and Labwatch
• Experience with DCS and/or PLC coding including but not limited to DeltaV, Allen Bradley, and Siemens

Knowledge, Skills, Abilities

• Knowledge of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annex 11 etc.) and guidelines (e.g. FDA, MHRA Data integrity guidelines, etc.) around quality systems and computer system validation in Biotech and/or Pharmaceutical industry
• Excellent Communication and listening skills
• Ability to build and maintain strong collaborative relationships across multiple departments
• Microsoft Office and database management skills

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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