Biopharmaceutical – Senior Project Manager Cqv

Biopharmaceutical – Senior Project Manager Cqv

Requirements

• 12+ years of experience in engineering / project management of various equipment and facilities within the pharmaceutical/biotech industry, with knowledge of requirements for a cGMP operation.
• Sterile filling experience is required.
• Previous experience in Management of big capital projects is required.
• Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
• Possess mentorship skills, to coach and develop junior and intermediate employees.
• Basic knowledge of AutoCAD.
• Engineering degree, preferably in Mechanical, Chemical, Electrical Engineering.

Responsibilities

• Provide technical guidance into the engineering assessments, design, project management, commissioning and start-up of equipment and facilities, for upgrades, renovations and expansions of client facilities and processes.
• Lead or support project execution from feasibility through to project completion/handover, including all project stages such as: Feasibility Assessments, Concept Design, Basic Design, Detailed Design, Procurement, Construction / Installation, Project Controls – Monitoring, Commissioning & Qualification.
• Prepare business cases, with project purpose, risks, budget, schedule, resource requirements.
• Manage other engineering design firms, equipment vendors, construction firms and internal / external stakeholders as required to execute projects.
• Review technical documentation such as P&IDs, specifications, layouts, manuals, datasheets.
• Integrate safety into the design and execution of all projects (HAZOP reviews, PHSRs, design reviews with EHS representatives).
• Prepare/review automation sequences, as required for Process Automation.
• Engage and coordinate with other engineering disciplines and other cross-functional departments (Process, automation, building / facilities, procurement, construction management, commissioning, qualification & validation, manufacturing operations, EHS, quality & compliance).
• Facilitate project management tools throughout the execution of projects, such as procurement tracking, vendor management, meeting minutes / action lists, risk register log, schedule updates, project updates.
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Travel may be occasionally required for meetings with equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation, construction, commissioning, qualification & validation phases.
• You may be involved with other aspects such as client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
• Visit construction and installation sites, wear necessary safety PPE.
• Supervise contractors during critical installations of process equipment and associated utilities.
• Other duties as assigned by client, and/or MMR, based on workload and project requirements.
• As this position requires working on client sites, you will need to comply with the client’s safety rules including mandatory vaccination policies for COVID-19, where applicable.

Preferred Qualifications

• Certification in Project Management would be an asset.
• Ability to travel to the US would be an asset.