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Validation Specialist III
Ref No.: 15-04077
Location: Swiftwater,, Pennsylvania
 The Validation Specialist will be responsible for generating validation protocols and reports, compile data packs and analyze data for aspect of the processes such as hold time, formulation, filling, CCIT, shipping and Extractable/Leachables. 
Formulation and/or Filling Validation
Recent hands on experience executing qualifications or  process validations For filling, significant experience from production or engineering assignments to have in-depth knowledge of vial and/or syringe filling equipment sufficient to identify process CPP's and generate detailed  validation protocol requirements and execution For formulation demonstrated experience with mixing and filtration process validation.
Hands on execution is required

Experience: 3 to 9 years.  Experience in, Process Validation (formulation and/or filling)
Performance Qualification, E&L, CCIT, shipping validation and/or Filter Validation
Skills: Skills, MS Office 2010, E Doc, Pharmaceutical Validation, Bio Pharma Validation, Validation execution, Cleaning Validation Technical writing abilities and good time management.  Strong root cause analysis skills with cGMP experience.  To be able to establish working relationships with other support and production areas in order to gather all of the necessary information required.
Must be proficient in E Doc with a working knowledge of templates, workflows and approval processProficient in MS Word, Excel, Powerpoint and OutlookInteract well with a diverse group of individualsSelf motivated and willing to be pro active in resolving issues Demonstrate the ability to successfully interface with QA personnel.
Excellent Verbal and written communication skills.   Ability to work in a team environment.

Education: BS/MS in Engineering, Life Science or Physical Science