CSV Analyst

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

Join our IT team at Thermo Fisher Scientific and contribute to our Computer Systems Validation (CSV) activities supporting spreadsheet solutions used within regulated environments. As a Systems Analyst II you will be responsible for the preparation execution and maintenance of validation deliverables throughout the validation lifecycle with a primary focus on Microsoft Excel spreadsheet validation.

Work closely with Business Quality IT and other cross-functional stakeholders to understand intended use and requirements assess GxP impact and risk and determine appropriate risk-based validation activities. Author and execute validation documentation and testing manage deviations and defects and support change control activities to ensure spreadsheets and applicable computerized systems remain in a validated state and compliant with applicable GxP and regulatory requirements.

REQUIREMENTS:

Bachelors Degree in Engineering Computer Science Information Systems Life Sciences Quality or related field with 3 years of relevant CSV experience

Strong knowledge of CSV GxP FDA requirements data integrity principles and SDLC within a regulated environment

Hands-on experience in Microsoft Excel spreadsheet validation including formulas calculations functions macros where applicable data controls protection features and risk assessment

Ability to independently author and execute validation deliverables including Validation Plans requirements risk assessments Test Plans IQ/OQ/PQ protocols Traceability Matrices and Validation Summary Reports

Experience executing validation testing documenting objective evidence and results and managing deviations test exceptions and defects through resolution

Experience with validation and test management tools such as HP ALM/ALM; knowledge of MasterControl and ServiceNow is preferred

Knowledge of change control and maintaining computerized systems and spreadsheets in a validated state

Strong technical writing analytical problem-solving and communication skills with the ability to work independently and collaborate with cross-functional stakeholders