OVERVIEW

Our client has an immediate need for three Process Validation specialists to support a pharmaceutical / biomedical project.  Contact us if you are immediately available and have the relevant education and prior experience conducting VALIDATIONS in one of these areas:

• Biological Reagents; specifically, In Vitro Diagnostic (IVD) Immunoassays
• Biomedical Instrumentation Manufacturing
• Measurement Methods and Analytical Chemistry Equipment

Staffing decisions for this project will be made quickly. 

JOB DETAILS

Type:                   Contract … 4 to 6 months
Experience:        5 to 10 years
Education:          Bachelors degree: engineering, chemistry or biological sciences preferred

JOB REQUIREMENTS

Candidates must have significant experience and a demonstrated understanding of US and International regulatory requirements for validation in one of the following areas:

• biological reagents
• biomedical instruments
• analytical chemistry equipment

Prior application in performing gap assessments and remediation plans in these respective areas will be a strong plus.

DESIRED CHARACTERISTICS

• Candidates must demonstrate strong communication and organizational skills in addition to the technical background required.

RESPONSIBILITIES / JOB DUTIES

• Develop process flow maps
• Facilitate and document development of Process Failure Mode and Effects Analyses (PFMEA)
• Review and categorize existing validation data to establish and understand gaps in validation data
• Provide expert opinion as to what will be needed to fill gaps.