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Full-time
bachelor degree
Posted 31d ago
~40 hrs/week
Responsibilities
Lead the design, commissioning, qualification, and project management of biopharmaceutical equipment and facilities from feasibility to handover. Coordinate cross-functional departments and manage external vendors to ensure successful project execution and safety compliance.
Requirements
Requires over 10 years of biotech industry experience in project management, specifically with cGMP, capital, and greenfield projects. A degree in Mechanical, Chemical, or Electrical engineering is preferred, along with leadership and mentorship skills.
Full job description
Previous Pharmaceutical/Biotech experience is mandatory for this role.
MMR Consulting is a consulting firm specializing in the pharmaceutical and biotechnology industries. Our services include Project Management, Process, Automation, Facilities and Equipment CQV.
MMR Consulting has offices in Canada, USA, and Australia.
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
Commissioning & Qualification
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.
Qualifications
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.
Equal Employment Opportunity and Reasonable Accommodations
MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.
MMR Consulting Inc. and its dedicated team of experienced consultants are committed to delivering high quality, robust solutions for the Pharmaceutical and Biotechnology industries. Our expertise includes Engineering (Process, Automation, Facilities), Capital Project Management of large/complex projects and programs, Commissioning Qualification Validation, and GMP Compliance services.
Offices: Loker Ave E, Suite 110, Carlsbad, California 92010, US · 2500 Regency Pkwy, Raleigh, North Carolina, US · 15255 S 94th Ave, 5, Chicago, Illinois 60462, US · 81 Zenway Blvd, 3, Toronto, Ontario L4H 0S5, CA · 171 Clarence St, 10, Australia, New South Wales 2000, AU
Capital Project ManagementCapital Project Controlsand Construction ManagementBiotechnologyManagement ConsultingLife ScienceIndustrial Automation