Vitros Validation Scientist (ONSITE)

Overview

On Site
Depends on Experience
Contract - W2
No Travel Required

Skills

Validation
MicroSlide technology
root-cause investigation
raw material validation
FDA
ISO
USDA regulations
QO Change Control
data analysis
LIMS
Excel
Minitab
risk assessment
FMEA
FMECA
Hazard Analysis
feasibility trials
technical reporting
project leadership
multi-tasking
organizational skills
communication skills
presentation skills
regulatory compliance
GMP
quality systems
team collaboration
material implementation
scientific writing
Chemistry
Biology
Biotechnology
Chemical Engineering.

Job Details

Please note that this is a 12+ contract position ONSITE in Rochester, NY

No C2C or H1 visas. Just available in W2 basis

Qualifications

  • Minimum BS degree in a scientific field (Chemistry, Biology, Biotechnology, or Chemical Engineering preferred); MS or PhD preferred

  • 5 7 years of experience working in a regulated environment (FDA, ISO, USDA, etc.)

  • Experience with VITROS MicroSlide technology required

  • Experience with QO Change Control systems (or equivalent) required

  • Experience with data analysis in LIMS, Excel, and Minitab (or equivalent) required

  • Demonstrated validation experience required; 2+ years preferred

  • Strong organizational skills, with ability to multi-task and prioritize multiple projects

Job Description

Position Summary
The Validation Scientist organizes and leads moderately complex validation projects, primarily focused on the validation of new supplies of MicroSlide raw materials, such as those replacing obsolete materials (e.g., chemicals and biologicals). This position will work independently and as a team member to conduct root-cause investigations of factory production failures as needed, develop test designs to evaluate failure impact on product performance, and assess residual product risk. Data is analyzed and findings documented in technical reports with recommendations for product fitness for use.

Primary Responsibilities

  1. Lead multiple projects concurrently

  2. Plan, lead, and document feasibility trials for new raw and manufacturing materials

  3. Create and/or update risk assessments (e.g., FMEA, FMECA, Hazard Analysis)

  4. Write validation plans and reports

  5. Oversee implementation of validated materials into production

  6. Communicate results to management and cross-functional teams; provide status updates to senior leadership as needed

Other Responsibilities

  1. Demonstrate effective communication and presentation skills

  2. Show schedule flexibility based on business needs

  3. Adhere to all quality, regulatory, and safety guidelines

  4. Stay current with individual and company training plans

Applicants must provide their phone number. Reference job number is A4874

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