Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
This position will work within Pharma Services Group to support computer system validation (CSV) services and provide a world-class commerce experience for Clinical Trials Division (CTD) customers. The CSV engineer is responsible for managing, developing and implementing validation protocols and test procedures with required validation documentation to ensure products meet with appropriate regulatory agency validation requirements, internal company standards and industry current practices. Oversees and reviews validation processes and procedures for the IT Department. Make recommendations for changes and improvements.
Roles & Responsibilities
- Assist with development and maintenance of validation methodology to guide software development, validation and maintenance in accordance with applicable Quality/Regulatory requirements, FDA guidance documents on software validation and industry best practices, as directed.
- Assist with development and maintenance of validation strategies, policies and SOPs implementing a predicate rule, risk-based approach to fully support the attainment and maintenance of a validated state of compliance for all regulated computerized systems, as directed.
- Provide interpretation and recommendations on compliance with FDA and EU Regulations regarding Validation related issues, i.e., Electronic Records/Electronic Signatures.
- Provide IT Department oversight of the validation of software and qualification of computing infrastructure to ensure validation is correctly and effectively implemented.
- Perform periodic review of software applications and formal documentation (including, but not limited to: policies, standard operating procedures, work instructions, etc.), as applicable.
- Provide IT Department oversight of the creation, collection, execution, approval and archiving of all validation lifecycle documentation related to the validation of CTD software and hardware systems, including but not limited to: VP, URS, FRS, FRA, IQ, OQ, PQ, and VSR.
- Partner with IT staff to provide validation guidance to ensure compliance with validation methodology, policies and SOPs.
- Responsible for development, maintenance and management of IT quality metrics including recommendations and assistance with implementation of improvement initiatives.
- Informs management of issues identified during qualification and validation activities.
- Recommends appropriate actions to address the issues.
- Build customer allegiance by actively seeking information to understand both internal and external customers’ circumstances, problems, expectations and needs.
- Applies Good Manufacturing Principles in all areas of responsibility.
- Demonstrates and drives the Thermo Fisher values – Integrity, Intensity, Involvement and Innovation (The Four I’s).
- Perform duties at the direction of IT Management and the Senior Validation Engineers/Analysts in a team environment.
- Other duties may be assigned to meet business needs.
- Work in a geographically separated team in different time zones.
- Contribute to innovation and process improvement efforts.
- Bachelor or Master Degree (or higher) from an accredited university.
- 5+ years of experience in an FDA-regulated environment.
- 5+ years of pharmaceutical Quality Assurance or Validation experience is preferred.
- Knowledge on HP/Microfocus ALM is plus.
Thermo Fisher Scientific
Thermo Fisher Scientific is an American provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry (including in the biotechnology and pharmaceutical sectors). Based in Waltham, Massachusetts, Thermo Fisher was created in 2006 by the merger of Thermo Electron and Fisher Scientific, to form a company with US$ 9 billion.