Junior Validation Specialist

Reference #PHARMA-JRVS

Location: Philadelphia

The Junior Validation Specialist will work closely with the project manager and team to prepare commissioning/qualification/validation documents and assist in their execution. The role requires a familiarity with pharmaceutical terminology and environments.

Responsibilities

• Validation Document Preparation Write/prepare IQ and OQ protocols and reports.
• Write/prepare PQ protocols and reports.
• SWI/SOP Preparation Write/prepare SWIs (Standard Work Instructions)
• Write/prepare SOPs (Standard Operating Procedures)
• Prepare Meeting Minutes Attend project meetings and take notes as required.
• Compile notes into official meeting minutes and issue the minutes as required to the project team.
• Deviation closure assistance Write/prepare deviation documentation with input from team.
• Assist with deviation closure and obtaining approval signatures.
• Commissioning/Validation document execution (autoclaves, utilities, process equipment, etc.) Assist in document execution.
• Assist in operation of thermal mapping equipment.

Ideal Candidate

• Preferably an Engineer with co-op experience in the pharma industry
• Able to read a P&ID and piping layouts
• Knowledge of Microsoft Word, Excel, Power Point, and Project
• Good verbal and written communication skills
• Self starter
• Adaptable and good with change
• Able to work in a tough environment toward aggressive schedules
• Kaye Validator 2000 experience