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Validation Specialist

Location

Whippany, NJ, USA

Department

Technical Services

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The Validation Specialist will conduct process validation studies for manufacturing and packaging processes

  • Provides technical assistance, as needed, for manufacturing and engineering troubleshooting
  • Responsible for the coordination of supportive validation activities (such as laboratory testing, calibration, scale-up and engineering studies) and assurance that the necessary project documentation is complete, accurate and in compliance with cGMP regulations.

 

Responsibilities

  • Generate, review, approve and maintain Validation Master Plan and Summary Reports and other Process validation lifecycle documents.
  • Evaluate Process validation projects to establish technically and scientifically sound protocols and test plans.
  • Execute protocols by carrying out the pre-approved testing in the operations and laboratory areas.
  • Collect and analyze all data, write final reports and obtain approvals.
  • Review technical documentation (batch records, SOPs, calibration records, preventive maintenance work orders, protocols, reports) for continuity and accuracy.
  • Perform gap assessments and remediation as required on legacy validation packages.
  • Write SOPs and protocols to support departmental programs and projects.
  • Coordinate successful execution of projects by working effectively with cross-functional groups.
  • May interface with the FDA and customers during site audits to respond to validation-related questions
  • May be involved in investigation and root cause analysis for incidents reported on validated systems
  • Other duties as assigned
Qualifications
  • At least 5 years of demonstrated direct (hands-on) validation experience in at least three of the following areas: Process Validation, Cleaning validation, tablet manufacturing/finishing, sterile/aseptic operations, utilities qualification, active ingredient synthesis, automated controller/computer qualification.
  • Ability to work harmoniously and effectively with others in a fast-paced environment.
  • Ability to effectively communicate technical information in a clear, concise manner within a GMP-regulated environment
  • Flexibility to work off-hours and weekends as required to support manufacturing plant projects
  • Ability to effectively manage multiple projects simultaneously (3-6 typical)
  • May be required to wear personal protective equipment
  • May be required to move about the facility
  • May be required to remain sedentary for periods of time
  • Bachelor’s degree in Engineering, in a scientific discipline, or equivalent experience