Halo Pharmaceuticals

Validation Specialist

US-NJ-Whippany
Type
Regular Full-Time

Overview

The Validation Specialist will conducts qualification and validation studies for manufacturing processes, equipment, and utitlities

  • 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

  • Evaluate qualification and validation projects to establish technically and scientifically sound protocols and test plans.
  • Execute protocols by carrying out the preapproved testing in the operations and laboratory areas.
  • Collect and analyze all data, write final report 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 qualification and validation packages.
  • Write SOPs and protocols to support departmental programs and projects.
  • Evaluate, maintain and operate validation instrumentation as required in order to support assigned projects (examples: Kaye Validator 2000, dew point monitor).
  • Coordinate successful execution of projects by working effectively with cross-functional groups.
  • May be involved in investigation and root cause analysis for incidents reported on validated systems

















Qualifications

  • Bachelor’s degree in Engineering, or in a scientific discipline, or equivalent experience
  • 5+ years of experience in pharmaceutical industry
  • Ability to work harmoniously and effectively with others in a fast-paced environment.
  • Ability to effetively 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)









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