Senior CQV Manager | Packaging Systems Lead

Visium Resources, Inc.; Portland (OR); On-site; USD 150,000 - 190,000; Full time

Job summary

Visium Resources, Inc. is seeking a Senior CQV Manager/Lead to oversee filling and packaging operations in a sterile/aseptic pharmaceutical environment. The role involves design/ redesign, installation, startup/ commissioning, qualification, and ongoing support for packaging equipment systems.

The candidate should demonstrate leadership and technical ability to independently manage resources and activities across multiple projects, including during shutdowns or extended hours as needed.

Qualifications

• 6+ years in a GxP environment for design or operation of pharmaceutical packaging operations, incl. sterile/aseptic manufacturing.

Responsibilities

• Lead or participate in design or operations of packaging pharmaceutical products into final forms and containers (fill/finish, vials, syringes).
• Create User Requirements Specifications (URS) for ongoing operations or new projects in collaboration with production/packaging groups.
• Create Design Specifications (DS) and Functional Specifications (FS) with vendors to implement solutions reducing contamination risks.
• Support FAT/SAT/Commissioning, Qualification of packaging systems.
• Coordinate cross-functional meetings to drive project progress and provide updates to management.
• Lead innovations in packaging technologies to support client needs.
• Perform reliability studies and optimization studies for packaging equipment usage.
• Other duties as assigned by client, and/or our client, including occasional off-hours work during installation/validation phases.

Skills

Leadership

Project management

GxP knowledge

Stakeholder coordination

Mechanical engineering

Education

Engineering degree (Mechanical preferred)

Job description

Visium Resources, Inc. is seeking a Senior CQV Manager/Lead to oversee filling and packaging operations in a sterile/aseptic pharmaceutical environment. The role involves design/ redesign, installation, startup/ commissioning, qualification, and ongoing support for packaging equipment systems.

The candidate should demonstrate leadership and technical ability to independently manage resources and activities across multiple projects, including during shutdowns or extended hours as needed.