Sr. CQV Manager / Lead

Visium Resources•Portland, OR

5d•Onsite

About The Position

Visium Resources is seeking a Senior CQV Manager / Lead to support filling and packaging operations in a sterile/aseptic pharmaceutical manufacturing environment. Work may cover design or redesign, installation, startup and commissioning, qualification, and operational support, including analysis, troubleshooting, and process improvements for filling and packaging equipment systems. The role requires technical and leadership skills to independently perform work or manage resources and activities related to filling and packaging operations. The job is located in Portland, Oregon. Candidates must be U.S. citizens or U.S. permanent residents. The position involves leading or participating in pharmaceutical product packaging operations, including fill/finish and packaging into vials, syringes, and other delivery systems. It also supports equipment reliability and optimization, contamination-risk reduction, continuous improvement, project coordination, and documentation or execution of FAT/SAT, commissioning, and qualification activities. Occasional travel, off-hours work, shutdown support, or extended hours may be required, particularly during installation and commissioning/validation phases. The role may require lifting up to 50 pounds.

Requirements

College degree, bachelor's degree, or diploma in an engineering discipline; mechanical engineering is preferred.
At least 6 years of experience in a GxP environment, typically involving the design or operation of pharmaceutical packaging operations, including sterile/aseptic manufacturing.
Previous experience in the pharmaceutical or biotech industry, with knowledge of cGMP operation requirements.
Leadership skills and the ability to take initiative and lead projects involving multiple stakeholders, departments, and varying complexity.
Ability to oversee multiple projects and work in a challenging environment.
Ability to lift 50 pounds.
Must be a U.S. citizen or U.S. permanent resident.
Travel and/or off-hours work may be required occasionally.

Nice To Haves

Mechanical engineering education is preferred.

Responsibilities

Lead or participate in the design or operation of pharmaceutical packaging into final forms and containers through fill/finish and packaging, including vials, syringes, and other delivery systems.
Work with production and packaging groups to create User Requirements Specifications (URS) for ongoing operations or new projects.
Collaborate with vendors on packaging machinery, equipment systems, automation controls, materials, and consumables to create Design Specifications (DS) and Functional Specifications (FS) for solutions that reduce contamination risks and process failures.
Assess current packaging operations for troubleshooting, efficiency, and continuous improvement opportunities.
Spearhead packaging technology innovations to support existing client needs.
Perform reliability studies on packaging equipment.
Perform optimization studies to determine optimal use of packaging equipment systems in campaigns.
Support documentation and/or execution of FAT/SAT, commissioning, and qualification of packaging systems.
Coordinate meetings with cross-functional departments to drive project progress, facilitate decisions, and provide updates to higher management.
Perform other duties assigned by the client based on workload and project requirements.