Biopharmaceutical - CQV Lead/ PROJECT MANAGER

MMR Consulting; Raleigh (NC); On-site; USD 140,000 - 200,000; Full time

Job summary

MMR Consulting in Raleigh, NC seeks a senior Project Manager with biotech/biopharma focus to lead equipment and facilities projects on client sites.

Responsibilities include feasibility through handover, coordinating vendors, managing budgets and schedules, reviewing P&IDs and specifications, and ensuring cGMP compliance. Travel to US sites may be required; Greenfield experience is preferred.

Qualifications

• 10+ years of biotech industry experience in project management of equipment and facilities within pharma/biotech with knowledge of cGMP requirements.
• Previous PM capital projects experience is required.
• Previous Greenfield projects experience is required.
• Leadership skills to lead projects with multiple stakeholders and varying complexity.
• Mentorship skills to coach junior and intermediate staff.
• Basic knowledge of AutoCAD.
• Degree in Mechanical, Chemical, Electrical or related discipline.
• Certification in Project Management would be an asset.
• Travel may be required; ability to travel to the US would be an asset.

Responsibilities

• Provide technical guidance into assessments, design, commissioning and start-up of equipment and facilities for upgrades and expansions.
• Lead or support project execution from feasibility through to handover, including design, procurement, construction, commissioning and validation.
• Prepare business cases with purpose, risks, budget, schedule and resources.
• Coordinate with design firms, vendors, construction firms and stakeholders to execute projects.
• Review technical documentation such as P&IDs, specifications, layouts and datasheets.
• Ensure safety integration in design and execution (HAZOP, PHSRs, design reviews).
• Engage cross-functional teams (Process, Automation, Facilities, Procurement, EHS, Quality).
• Travel for meetings with vendors or FATs; may support shutdowns or extended hours.

Skills

Project management

Leadership

Mentorship

cGMP

AutoCAD

Travel readiness

Education

Bachelor info in Mechanical/Chemical/Electrical or related discipline

PM Certification (asset)

Tools

AutoCAD

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.