CLEANING Validation Specialist Position Available In Monroe, Pennsylvania
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Company:
Unclassified
Salary:
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Job Description
Job Description:
CLEANING
Validation Specialist III – Biologics
MUST HAVE
Cleaning validation experience Strong communication skills Abilityto manage, execute and troubleshoot on their own Strong MicrosoftSuite skills Duties
- Experience in cleaning validation in thebiologics or vaccine industry to include the following: oExperience in authoring, reviewing, executing and approvingvalidation documents o Interface with Quality organization and theability to defend rationale in validation documents o Ability todevelop cleaning cycle and lead the investigation or troubleshooting o Ability to review and analyze data
- Cleaning Validationexperience o Acceptance criteria determination o Sampling plans andsample size determination o Rinse and Swab sampling experience oBracketing and worse case rating o QC testing requirements o Dirtyhold times and clean hold times
Basic Qualifications:
- Experienceutilizing Microsoft Word, Excel, and Outlook
- Experience writingand revising documents (e.g. testing methods, protocols, reports)
- Experience performing testing in a GMP setting
- MS Projectexperience Skills
- Proficiency in utilizing documentation systemto author protocols and reports
- Experience participating in teamsand collaborative work environments.
- Good communication skills(verbal and written), math skills, general computer skills
- Teamenvironment a must
- E Doc/GEODE experience with a workingknowledge of templates, workflows and approval process
- Strongroot cause analysis with cGMP experience. Education
- BS/MS inScience (e.
g. Chemistry, Biochemistry, Analytical Chemistry) orEngineering (Chemical or Biochemical) with 2 total years ofexperience working in a biologic, vaccine or pharma industry forimmediate response, send resume to agautam@valiantiq.com