Sr. CQV Manager / Lead

Visium Resources, Inc.; Portland (OR); Vor Ort; USD 150.000 - 190.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

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

Aufgaben

• 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.

Kenntnisse

Leadership

Project management

GxP knowledge

Stakeholder coordination

Mechanical engineering

Ausbildung

Engineering degree (Mechanical preferred)

Jobbeschreibung

Visium Resources is looking for a Sr. CQV Manager / Lead who will work on the filling and packaging operations within a sterile / aseptic pharmaceutical manufacturing environment. Tasks may include all or in part, design / re-design, installation, start-up / commissioning, qualification as well as operation support for analysis, trouble shooting and / or process improvements of the filling / packaging equipment systems. The ideal candidate should possess technical as well as leadership skills to independently perform or manage resources and activities related to the filling and packaging operations.

• Job location is Portland, OR.
• JOB ID: 11953

Accountabilities:

• Lead or participate in design or operations of packaging pharmaceutical products into their final forms and containers by fill / finish and packaging like, 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 for packaging machinery, equipment systems, automation controls, materials, and consumables, to create Design Specifications (DS) and Functional Specifications (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 our client, based on workload and project requirements.
• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.

Experience & Education:

• College / Bachelors' Degree or Diploma in Engineering discipline, preferable Mechanical
• 6+ years in GxP environment typically for design or operation of pharmaceutical packaging operations, including sterile / aseptic manufacturing.
• Previous experience in the pharmaceutical / biotech industry, with knowledge of requirements for a cGMP operation
• Possess leadership skills and be able to take initiative to 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.
• Travel and / or off-hours work may be required on occasion!