Overview

PBE Expert Inc is a consulting company in Pharmaceuticals, Biotechnology, Cannabis, Morphine, Medical Devices, Natural Health Products (NHP), Cosmetics, Food Supplements and Food Industries that works in Canada but also internationally.

Responsibilities

• Process engineering, Layout: URS, BOD, DDE, PFD, P&ID.
• GMP compliance audit of sites & Design Review.
• Commissioning & Qualification of equipment, utilities and pharma / ICH systems Q9 : FAT, SAT, DQ, IQ, OQ, PQ.
• Manufacturing Process Validation, Cleaning & Sterilization Validation according to the new FDA2011 & ANSM2015 guides.
• Computer validation (CSV), according to CFR21, part 11, GAMP.
• Project management, GANT.
• The candidate will also be involved in contributing to the commercial development of PBE Expert Inc (Bonus$$$).

Requirements

• 5 years experience in Clean Process Design.
• Mastery of ASME BPE, IS...