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Engineering Manager

Charlotte, NC
$120,000 - $175,000

Responsibilities

  • The Engineering Manager will provide mentorship and direction to staff on execution of the Qualification/Validation Lifecycle. Complete capital projects (new projects/project expansions/up-gradation of existing facilities) on time and within the approved budget.
  • Develop a strong documentation package, involving form conceptual study to various phases of project like basic engineering, detail engineering, pre-commissioning / commissioning of equipment.
  • Preparation for various regulatory inspections/audits and active participation during audits, as needed.
  • Develop Block Flow Diagrams, Process Flow Diagrams, Piping and instrumentation Diagrams, Mass and utility balances, and safety analysis of biopharmaceutical processes.
  • Provide conceptual, detailed design, project planning, and execution and qualification of biopharmaceutical facilities as per cGMP requirements.
  • Process valve matrix, process sequence logics, functional design specification (FDS), process control sequences, and CIP/SIP sequences, etc.
  • Develop / review URS, Tendering, preparation of technical comparisons, DQ, FAT, recipient of equipment, SAT, commissioning, qualification and validation.
  • Relocation provided, $120K-$175K.

Requirements

  • The Engineering Manager will have BS or MS degree with a engineering or chemistry major.
  • At least 10 years of relevant experience in the pharmaceutical industry.
  • Thorough understanding of aseptic filling unit operations and controls, as well as drug product process validation is necessary.
  • Resource forecasting experience.
  • Must be legally eligible to work in the U.S. and have a stable work history. Sponsorship is not available.





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