Job Description
Job Description
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.
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!
\nCompany Description
Visium Resources is an award-winning employment firm with a mission to match talented individuals with highly successful organizations. At Visium, our company’s success is based on your success. When you work with us, you are never “just a number”. You are our most important asset. Here, you will know us by name through our regular visits to client sites and even occasional luncheons. We will always be there when you need assistance and will always go the extra mile to ensure that you are as successful as possible. Whether you're looking for contract, contract-to-hire or permanent opportunities, we firmly believe there is no employment agency that will work harder for you than Visium. Visium Resources is an equal opportunity employer and values diversity. All employment is decided based on qualifications, merit and business need.
Company Description
Visium Resources is an award-winning employment firm with a mission to match talented individuals with highly successful organizations. At Visium, our company’s success is based on your success. When you work with us, you are never “just a number”. You are our most important asset. Here, you will know us by name through our regular visits to client sites and even occasional luncheons. We will always be there when you need assistance and will always go the extra mile to ensure that you are as successful as possible. Whether you're looking for contract, contract-to-hire or permanent opportunities, we firmly believe there is no employment agency that will work harder for you than Visium. Visium Resources is an equal opportunity employer and values diversity. All employment is decided based on qualifications, merit and business need.