Biopharmaceutical - CQV Lead/ PROJECT MANAGER at MMR CONSULTING in Raleigh, North Carolina

Job description

• This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of specialists involved in project management, commissioning and qualification, of equipment, systems and facilities.
• This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of specialists involved in the design, commissioning & qualification, start-up and project management of various processes, systems and facilities. The work will require working out of client’s facilities.
• The work will require working out of the client’s facilities in Raleigh, North Carolina.

Responsibilities

• Provide technical guidance into the 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
• Prepare business cases, with project purpose, risks, budget, schedule, resource requirements.
• Manage other design firms, equipment vendors, construction firms and internal / external stakeholders as required to execute projects.
• Manage Capital 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 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.

Requirements

• Previous Pharmaceutical/Biotech experience is mandatory for this role.
• 10+ years of experience in the biotech industry in project management of various equipment and facilities within the pharmaceutical/biotech industry, with knowledge of requirements for a cGMP operation.
• Previous PM capital projects experience is required.
• Previous Greenfield projects experience 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.
• Degree, preferably in Mechanical, Chemical, Electrical or other industry related discipline.
• Certification in Project Management would be an asset.
• Travel may be required on occasion. Ability to travel to the US would be an asset.

Skills

Required

• Leadership skills
• Mentorship skills
• Basic knowledge of AutoCAD
• Project management
• Knowledge of cGMP operations

Preferred

• Certification in Project Management
• Ability to travel to the US