Senior Filling & Finish CQV Lead – Packaging Ops

MMR Consulting; San Francisco (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

MMR Consulting is seeking an experienced packaging engineering leader to join a team supporting sterile/aseptic pharmaceutical manufacturing. You will lead and participate in design, commissioning, and qualification of packaging systems, working across multiple projects and stakeholders.

The role involves collaboration with clients, vendors, and internal teams, with possible travel to client facilities (Portland, OR).

Qualifications

• Bachelor's or diploma in Engineering, preferably Mechanical.
• 8+ years in GxP environment for design/operation of pharmaceutical packaging operations, including sterile/aseptic manufacturing.
• Previous experience in pharma/biotech with GMP knowledge.
• Leadership to lead projects with multiple stakeholders.
• Ability to manage 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/operation of packaging products into final forms.
• Work with production and packaging groups to create URS for ongoing operations or new projects.
• Collaborate with vendors to create DS/FS to implement solutions for reducing contamination risks & process failures.
• Assess current packaging operations for troubleshooting, efficiencies and continuous improvement opportunities.
• Spearhead innovations in packaging technologies to support existing client needs.
• Perform reliability studies on packaging equipment.
• Perform optimization studies for the optimal use of packaging equipment systems for use in campaigns.
• Support documentation and/or execution of FAT/SAT/ Commissioning, Qualification of packaging systems.
• Coordinate meetings with cross-functional departments to drive project progress, facilitate decisions, provide updates to higher management.
• Other duties as assigned by client, and/or MMR, based on workload and project requirements.
• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning/validation phases.

Skills

Leadership

Project Management

Packaging Design

GxP Experience

Education

Engineering degree

Mechanical

Job description

MMR Consulting is seeking an experienced packaging engineering leader to join a team supporting sterile/aseptic pharmaceutical manufacturing. You will lead and participate in design, commissioning, and qualification of packaging systems, working across multiple projects and stakeholders.

The role involves collaboration with clients, vendors, and internal teams, with possible travel to client facilities (Portland, OR).