process safety engineer consultant

Summary:

Designs, specifies and commissions new and renovated biopharmaceutical process equipment.

Essential Duties and Responsibilities

• Designs and specifies cGMP process equipment, piping, and controls.
  

• Scope and update functional Design Specifications (FDS) for automation updates on process equipment.
  

• Manages small-to-mid sized projects related to process equipment and manufacturing. Types of equipment exposed to are as follows: WFI, CIP, Bioreactors, Centrifuges, Chromatography, Media Prep, Buffer Prep and UFDF.
  

• Assists in the design review, site acceptance and installation of equipment.
  

• Updates piping and instrumentation diagrams (P&ID) and other related drawings. Updates 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.
  

• Identifies & implements corrective/preventative actions (CAPAs) for existing qualified GMP equipment and manufacturing processes through site change control process.
  

• Identifies & implements process improvements for manufacturing processes and utilities.
  

• 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.
  
• Assists with tech transfer activities, such as process scale up and New Product Introductions (NPIs).
  

Education and experience:

• Requires BS/BEng in Chemical, Process or Mechanical engineering with 3 - 5 years related experience.
  
• Direct experience with biopharmaceutical process equipment is preferred. May substitute relevant experience for education.
  

• Experience with compliance systems that document site change controls and corrective actions (CAPAs) e.g., Track wise, Process Compliance, would be hugely beneficial but not a requirement.
  
• GMP and GDP experience would be desirable.