Manufacturing Engineer

The Manufacturing Engineer will be responsible for assigned duties related to the design, procurement, installation, commissioning and qualification of new pharmaceutical processes and equipment. The Manufacturing Engineer is responsible for commissioning manufacturing systems and inspecting the construction and operation of the equipment. Working closely with maintenance, the engineer will provide sound advice as a subject matter expert. This position will ensure all projects are delivered to meet the project timelines, budgets and applicable quality standards (GXP, ISO, ICH) as well as the applicable regulatory legislation (OHS, CSA, NFPA, CEPA, etc).

• Prioritizing and executing assigned project deliverables, including adherence to budgets and schedules, coordinating project startup, commissioning and qualification activities with internal and external groups.
• Startup of new process equipment and instrumentation, troubleshooting equipment and instrumentation during commissioning activities.
• Assembling and reviewing Turn Over Packages (TOP) for systems and equipment. Developing Equipment Qualification protocols and execution of these protocols. Data collection and statistical analysis.
• Developing and updating ACAD drawings. Reviewing and updating "As Built" drawings in coordination with outside contractors.
• Coordinating project startup, commissioning and validation activities with internal and external groups.
• Supporting trades people (electrical, mechanical, and structural) by providing advice or guidance.
• Conferring with vendors to determine product specifications, purchase equipment, materials or parts, materials of construction (“MOC”) and evaluate products according to quality standards.
• ·Processing, equipment and engineering improvements/modifications to existing manufacturing equipment. This includes mechanical, electrical and instrumentation installation and improvements.
• ·Researching technical information for the installation, installation, maintenance, and operation of instruments and equipment. Determining the critical testing requirements for instrumentation and equipment prior to qualification.
• ·Assisting maintenance department with repair, calibration, and sourcing replacement parts, as required.
• ·Participating in project meetings between engineering, manufacturing and client.
• Participate in P&D, HAZOP, PHA and other design reviews
• Organizing project paperwork, drawings and files
• ·Additional duties assigned, based on business needs and the department supervisor’s request

• Ability to communicate effectively with departments and personnel.
• Excellent computer skills; including Excel, Word, MS Project and AutoCAD.
• Ability to anticipate issues and trends which could impact clients and projects.
• Energetic team player but able to work effectively independently.
• Ability to function effectively under ongoing pressure and flexibility to change.
• Enthusiastic and willing to expand on responsibilities and professional abilities.
• Project management experience would be an asset.