Cleaning Validation Scientist

Job Summary

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.

Responsibilities

• 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.
• Coincides sample analysis with site chemistry, site microbiology, Innovation and Development (I&D) or outside laboratories.
• Determines surface areas for various equipment trains as well as individual pieces of equipment.
• Aids in product assessment using ingredient solubilities and toxicities by incorporating Acceptable Daily Exposure (ADE) for determining cleaning requirements.
• Aids in the revision of site Cleaning Validation SOPs.
• Aids in the initiation or revision of Risk Assessments related to Cleaning Validation/Verification projects.
• Aids in the generation of Protocols for cleaning studies.
• Aids in the generation of Investigations related to various cleaning issues.
• Aids in the laboratory by performing tasks such as reagent/solution preparation, residual detergent assessments, etc., in support of the Cleaning Programs.
• Aids 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.
• Aids the Cleaning Validation Leader(s)/Cleaning Validation Supervisor in the maintenance of the Cleaning Validation Master Plan and the Cleaning Validation Re-qualification Program.
• Aids 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.

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.

Typical Work Hours

Typical work hours are the standard first shift, however execution of protocols will often require work on nights and weekends to meet the production schedule. Flexibility with schedule is required.

Schedule

Schedule based on a 40-hour work week with the number of hours per day flexible to support protocol execution and production schedule.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at-will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.