Project Engineer
Description
Develop User Requirement Specifications (URS), and conduct project risk assessments that include constructability, hazard analysis and design/GMP reviews; Coordinate design qualification (DQ) and functional specifications (FRS) to ensure equipment align with system owner requirements; Engage and work with equipment vendors, Engineering firms and construction managements firms to ensure correct equipment, designs and technologies are selected; Develop project schedules and cost controls to ensure successful project implementation; Manage equipment FAT, installation, start-up, commissioning and successful hand over to production; Coordinate qualification/validation efforts and ensure necessary support to complete validation activities according to schedule; Follow all project management guidelines that are used internally by the organization.
Specific knowledge
Bachelor's degree in Electrical, Mechanical, Chemical or other related Engineering field; Minimum of five (5) to eight (8) years' experience in a highly automated manufacturing setting; Experience in the pharmaceutical industry; Good knowledge of the Microsoft software suite: Word, Excel, PowerPoint and MS Project; Familiar with HC, FDA, EU, WHO, EPA, OSHA; Good knowledge of the pharmaceutical production equipment; Godd knowledge of the Clean utilities & HVAC; Proficiency in spoken and written French and English; Self-starting, results-driven capacity for leadership and influence Concern for detail and work well done; Recognized ability to meet tight deadlines in a constantly changing environment; Strong sense of organization and ability to work on several projects at the same time.