Senior CQV Lead — Biopharma Projects

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

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.