Join to apply for the Associate Validation Analyst II role at Thermo Fisher Scientific.
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, with some PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).
Work Schedule
Standard (Mon-Fri).
Responsibilities
* Participate as a member of project teams, contributing to system enhancements, reviewing change requests, and ensuring effective communication and testing accuracy.
* Provide validation support for new releases and modifications to applications, including equipment qualifications, software upgrades, and retirements.
* Draft Change Controls, VDA, IQ, OQ documents for validated GMP hardware and software systems per SOP, from initial to pre-approval stages.
* Manage vendor installations on validated GMP hardware and software systems per SOP.
* Complete IQ, OQ documents for validated GMP hardware and software systems following SOP.
* Provide ongoing support to users during implementation and use of validated platforms, including training, support, and maintenance.
Requirements
* Bachelor’s degree or equivalent with relevant academic/vocational qualifications.
* Entry level to 2 years of Validation Analyst experience, GMP exposure to standalone hardware and software systems is advantageous.
* Experience leading vendor activities onsite.
* Strong analytical skills and attention to detail.
* Ability to work closely in a team environment.
* Good written and verbal communication skills.
* Proficiency in Microsoft Office Suite and other data analysis tools.
* Ability to meet deadlines and manage multiple tasks concurrently.
This hybrid role requires the first two months on-site at 80% for training, then at least 3 days a week on-site.
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