Process Safety Engineer Consultant

Summary: Designs, specifies and commissions new and renovated biopharmaceutical process equipment. Provides engineering support and problem solving for existing equipment and manufacturing processes.

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.