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).
Hybrid role: First two months on-site at 80% for training; thereafter, minimum of 3 days/week on-site.
**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 throughout the software development process (e.g., equipment qualifications, software upgrades, retirements).
- Draft Change Controls, VDA, IQ, OQ documents for validated GMP hardware and software systems per SOP.
- Manage vendor installations on validated GMP systems per SOP.
- Complete IQ, OQ documents for validated systems per SOP.
- Provide ongoing support to users during and after implementation, ensuring training, support, and maintenance.
**Requirements**
- Bachelor’s degree or equivalent with relevant academic/vocational qualifications.
- Entry level to 2 years’ validation experience, GMP exposure preferred.
- Experience leading vendor activities onsite.
- Strong analytical skills and attention to detail.
- Team-oriented with good communication skills.
- Proficiency in Microsoft Office Suite and data analysis tools.
- Ability to meet deadlines and manage multiple tasks concurrently.
**Additional Details**
- Not applicable seniority level.
- Full-time employment.
- Job function: Production, Supply Chain, Manufacturing.
- Industries: Pharmaceutical Manufacturing, Biotechnology Research.
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