Description

Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materialsJob DescriptionAs part of the Thermo Fisher Scientific team, you’ll 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 world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. DESCRIPTION:Participates in project teams to guide system enhancements, review change requests, and ensure accurate testing and communication. Provides validation support across the software development lifecycle, including drafting and executing GMP documentation (RA, Change Controls, IQ, OQ, PQ, TM, VS, SOP’s), managing vendor installations, and supporting equipment/software qualifications and upgrades. Delivers ongoing user support and maintenance for validated systems. REQUIREMENTS:-Bachelor's degree required, 2-5 years GMP experience preferrable in Validation Analyst work with GMP exposure to working on standalone hardware and software systems an advantage-Preferred Fields of Study: Computer Science, Information Technology, or related field -Client-focused approach with strong interpersonal skills, and strong oral and written communication skills and ability to teach others-Strong attention to details and problem-solving skills-Demonstrated competency with Microsoft Office Suite (Word, Excel, -PowerPoint, and Project). Proven ability to learn new computer software with minimum of instruction-Positive attitude, enthusiasm toward work, and the ability to work well with others-Effective organization and time management skills with the ability to adapt and adjust to changing priorities and manage multiple assignments with challenging/conflicting deadlines-Solid understanding of clinical trials operational processes and terminology and solid understanding of the software development life cycle (SDLC)-Strong troubleshooting skills and ability to analyze software defects, assess the cause of test failures, and explain how errors are produced-Ability to attain, maintain, and apply a working knowledge of GCPs, applicable SOPs/WPDs, and process maps-Ability to review and critique SDLC documentation including requirements, functional design, system design, and test plans. Ability to assess the cause of test failures-Demonstrated ability to coordinate project activities and work and communicate effectively on a multi-disciplinary teamTravel may be required Hybrid role - First two months to be on-site 80% of time to complete required trainings, there after minimum of 3 days a week required.

Validation Analyst

Description

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