Cleaning Validation Scientist

Fresenius Kabi USA•Grand Island, NY

23h•$70,073 - $105,109•Onsite

About The Position

Responsible for assisting the Cleaning Validation Leader and/ or Supervisor in the coordination of the overall Cleaning Validation Policy from a site and corporate perspective to insure compliance. Performs cleaning validation chemical and sampling/testing as required. This position reports directly to the Cleaning Validation Supervisor or Manager of Product Transfer and Product Validation. No employees report to this Scientist position. The Cleaning Validation Scientist position works directly with the Cleaning Validation Leader(s) and/or Cleaning Validation Supervisor. The scientist position works with operations and the appropriate laboratories for obtaining and submitting cleaning samples for testing and in some cases perform testing as required, etc. Responsible for the preparation of protocols/ reports, calculation of data, as well as verification and review of results as required by the Manager. All assigned projects will have a limited scope with no risk.

Requirements

Minimum of an Associate degree in Chemistry, Microbiology or other Science/Engineering related field Or minimum of an Associate Degree with closely related field experience and a minimum of two years’ experience in a pharmaceutical environment.
OR Minimum of a bachelor’s degree in Chemistry, Microbiology or other Science/Engineering related field Or Minimum of a Bachelor’s degree with other closely related field experience and minimal two years’ experience in a pharmaceutical environment.
Must possess good interpersonal skills and have good written and verbal communication skills.
Must possess proficient computer skills to prepare protocols, technical documents, etc.

Responsibilities

Assisting in all aspects of the site Cleaning Validation Program/SOP’s to ensure compliance.
Conducts the cleaning validation/verification studies including actual sampling and the coordination of the studies with operations to insure equipment availability, preparation of any hold notices, equipment out of service requirements, etc.
Coordinates sample analysis with site chemistry, site microbiology, Innovation and Development (I&D) or outside laboratories.
Determination of surface areas for various equipment trains as well as individual pieces of equipment.
Assists with product assessment using ingredient solubilities and toxicities by incorporating Acceptable Daily Exposure (ADE) for determining cleaning requirements.
Assist with the revision of site Cleaning Validation SOPs.
Assists with initiation or revision of Risk Assessments related to Cleaning Validation/Verification projects.
Assist with the generation of Protocols for cleaning studies.
Assist with the generation of Investigations related to various cleaning issues.
Assist in the laboratory by performing tasks such as reagent/solution preparation, residual detergent assessments, etc., in support of the Cleaning Programs.
Assists the Cleaning Validation Leader(s)/ Cleaning Validation Supervisor in the compilation of data, interpretation of results, investigations, etc., and Final Reports related to the Cleaning Validation Program.
Assists the Cleaning Validation Leader(s)/ Cleaning Validation Supervisor in the maintenance of the Cleaning Validation Master Plan and the Cleaning Validation Re-qualification Program.
Assists the Cleaning Validation Leader(s)/ Cleaning Validation Supervisor in coordinating/conducting cleaning procedure training, etc. as required by the Cleaning Validation Program.
Technical reviewer for tables and simple protocols and final reports (as assigned by manager).
Assumes additional duties and responsibilities as assigned by the Cleaning Validation Supervisor and management.