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Validation Specialist – Charlotte, NC

Responsibilities

  • The Validation Specialist is responsible for Oral Solid Dose (OSD) and Sterile manufacturing facilities.
  • Maintain all documentation pertaining to qualification and validation.
  • Experience in equipment and facility validation and / or qualification in GMP environment.
  • Responsible for preparing and executing commissioning and qualification documents for a variety of utility, facility and process equipment. This includes FATs, URSs, DQs, SATs, CTPs, IQs, OQs, PQs, PVs and other validation life cycle document.
  • Relocation provided. $70K-$85K.

Requirements

  • The Validation Specialist will have a BS degree in a scientific discipline.
  • 3+ years hands-on experience in conceptual, detailed design, project planning, execution and qualification of bio pharmaceutical facilities as per cGMP requirements.
  • Experience in developing Block Flow Diagrams, Process Flow Diagrams, Piping and instrumentation Diagrams, Mass and utility balances, safety analysis etc. of bio pharmaceutical processes.
  • Demonstrated experience with process valve matrix, process sequence logic, functional design specification (FDS), process control sequences, CIP/SIP sequences.
  • Experience reviewing/development of URS, Tendering, preparation of technical comparisons, DQ, FAT, SAT, commissioning, qualification and validation.
  • Must be legally eligible to work in the U.S. and have a stable work history. Sponsorship is not available.

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