CQV Packaging Lead – Sterile Fill/Finish (Relocation)

MMR Consulting; San Francisco (CA); On-site; USD 140,000 - 180,000; Full time

Job summary

MMR Consulting is hiring for a CQV lead role focused on filling and packaging operations in a sterile/aseptic pharmaceutical manufacturing environment. The position requires leading design, installation, start-up, and qualification activities, with responsibility for schedules, budgets, and cross-functional coordination.

The candidate should have 8+ years in GxP pharmaceutical packaging, strong leadership, and the ability to manage multiple projects in a fast-paced setting, with travel and

Qualifications

• 8+ years in GxP environment for design or operation of pharmaceutical packaging operations, including sterile/aseptic manufacturing.
• Experience in pharmaceutical/biotech industry with GMP operations.
• Leadership skills to lead projects with multiple stakeholders and departments.
• Ability to handle multiple projects in a fast-paced environment.
• Ability to lift 50 pounds.
• Travel and/or off-hours work may be required.

Responsibilities

• Lead or participate in design or operation of packaging pharmaceutical products in final forms and containers by fill/finish and packaging like vials, syringes, etc.
• Lead or support project execution from feasibility through project completion/handover.
• Develop and manage CQV strategies, plans, schedules, budgets, and resources.
• Communicate with senior leadership and site-level teams.
• Work with production and packaging groups to create URS for ongoing operations or new projects.
• Collaborate with vendors for packaging machinery, equipment systems, to create DS/FS for solutions reducing contamination risks & process failures
• Assess current packaging operations for troubleshooting, efficiencies and improvements
• Spearhead packaging tech innovations to support client needs
• Perform reliability studies on packaging equipment
• Perform optimization studies for packaging equipment use in campaigns
• Support FAT/SAT/ commissioning, qualification of packaging systems
• Coordinate meetings with cross-functional departments to drive progress
• Other duties as assigned by client and/or MMR
• Work may require shutdowns or extended hours during installation and validation phases

Skills

CQV leadership

GxP

Project management

Packaging operations

Education

Bachelor's in Engineering

Job description

MMR Consulting is hiring for a CQV lead role focused on filling and packaging operations in a sterile/aseptic pharmaceutical manufacturing environment. The position requires leading design, installation, start-up, and qualification activities, with responsibility for schedules, budgets, and cross-functional coordination.

The candidate should have 8+ years in GxP pharmaceutical packaging, strong leadership, and the ability to manage multiple projects in a fast-paced setting, with travel and