Collins McNicholas

Senior Project Engineer

This Senior Project Engineer role will involve designing and commissioning new and renovated process equipment. You will be providing support for problem solving and for existing equipment and manufacturing processes.

Responsibilities:

  • Manages projects related to process equipment and manufacturing.
  • Design and specifies cGMP process equipment, piping, and controls.
  • Support the design review, site acceptance and installation of equipment.
  • Prepares piping and instrumentation diagrams and other related drawings.
  • Develops Process Flow Diagrams for manufacturing processes.
  • Supports QA Validation department by preparation of design documents and assists in protocol execution.
  • Assists in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
  • Implements corrective/preventative actions for existing equipment and manufacturing processes.
  • Prepares engineering evaluations and test plans for and executes change control documentation.
  • May supervise mechanical, electrical, and automation contractors.
  • Maintains a clean and safe working environment by enforcing procedures, policies, and regulations.
  • Maintains company reputation by enforcing compliance with local, state, and federal regulations.

Requirements:

  • Minimum BA/BS Chemical, Biochemical or Mechanical engineering.
  • 6+ years of related experience
  • Experience with biopharmaceutical process equipment
  • Working knowledge of cGMPs and sanitary equipment design requirements.
  • Working knowledge of process control systems and automation.
  • Advanced knowledge of engineering documentation required for cGMP process equipment.
  • Substantial knowledge of clean room design & function and biopharmaceutical equipment.
  • Strong written and oral communication skills.
  • Ability to understand project plans and schedules.
  • Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.

For more information or to apply for this position, please call Ben Forde on 061-512270

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