Validation Scientist

Job Title: Validation Scientist
Location: Rochester, NY
Duration: 12 Months

Pay Rate: $52.50/hr on w2
 
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 that are replacing materials that have been obsoleted by a supplier (e.g. chemicals and biologicals). This position will work both independently and as a team member to conduct root-cause investigations of factory production failures as needed. Defines and develops test designs to evaluate the failure on product performance and to assess residual product risk. Analyzes data and documents findings in technical reports including a recommendation for the fitness of use of the product.
 
Position Summary:
Primary Responsibilities:

• Leadership of multiple projects concurrently.
• Plans, leads and documents feasibility trials for new raw materials and/or manufacturing materials.
• Creates and/or updates existing risk assessments (e.g. FMEA, FMECA and Hazard Analysis).
• Writes validation plans and reports.
• Implementation of validated materials into production.
• Effectively communicates results to management and cross-functional teams; summarizes and presents project status updates to senior leadership team as needed.

 
Other Responsibilities:

• Effective communication and presentation skills.
• Flexibility in schedule based on business need.
• Accountable for adhering to all quality, regulatory and safety guidelines.
• Accountable for staying current with individual and company training plan.

 
Minimum Education, Experience and Skills Required & Preferred:

• Minimum BS degree in scientific field (Chemistry, Biology, Biotechnology, or Chemical Engineering field preferred); MS or PhD preferred.
• 5-7 years of experience working in regulated environment (FDA, ISO, UDSA, etc.)
• Experience with VITROS MicroSlide technology required.
• Experience with QO Change Control system (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, ability to multi-task, and prioritize multiple projects.