Vitros Validation Scientist (ONSITE)

Vitros Validation Scientist (ONSITE)

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

Lead multiple projects concurrently

Plan, lead, and document feasibility trials

for new raw and manufacturing materials

Create and/or update

risk assessments

(e.g., FMEA, FMECA, Hazard Analysis)

Write

validation plans and reports

Oversee

implementation of validated materials into production

Communicate results

to management and cross-functional teams; provide status updates to senior leadership as needed

Other Responsibilities

Demonstrate effective

communication and presentation skills

Show

schedule flexibility

based on business needs

Adhere to all

quality, regulatory, and safety guidelines

Stay current with

individual and company training plans

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

Employers have access to artificial intelligence language tools (AI) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

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Dice Id:

NETSO

Position Id:

A4874