Job Details

  • Title: Validation Specialist
  • Code: RCI-9962118
  • Location: Swiftwater Pennsylvania (PA) 18370
  • Posted Date: 03/27/2020
  • Duration: 3-5 Months
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  Job Description

Responsible for generating development / validation protocols and reports, compiling data packs and analyzing data for adherence to established acceptance criteria.  Typical processes being developed / validated include mixing, filling, formulation, visual inspection and lyophilization, .  Studies supporting these processes include hold time, CCIT, stability, Part 4 compliance.  Experience Requirements:

  • Formulation process validation
  • Filling process validation
  • Aseptic Processing experience
  • Recent hands on experience executing 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 coordinate execution
  • For formulation demonstrated experience with mixing, dispense and filtration process validation.
Required:
  • 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.
  • Familiar with Extractables/Leachables.
  • Experience in, Process Validation (formulation, filling, visual inspection and/or lyophilization),Performance Qualification, E&L, CCIT and Part 4 compliance
  • Skills, MS Office 2010, E Doc, Pharmaceutical Validation, Bio Pharma Validation, Validation execution,
  • Must be proficient in E Doc with a working knowledge of templates, workflows and approval process
  • Proficient in MS Word, Excel, Powerpoint and Outlook