Validation Engineer III hos Celgene


Bothell, Washington Req #: 1902213
Location: Bothell, Washington, United States
Job Category: Technical Development
Work Location: 1522 217th Pl SE 98021
Organization: Bioengineering
Employee Status: Full-time
Job Type: Regular
Juno is looking to add a Validation Engineer to our team who will be responsible for the
Aseptic Processing Validation program and will represent Validation in cross functional efforts
to ensure patient safety ranging from microbial control strategy to closed system processing
implementation.

DUTIES AND RESPONSIBILITIES:

  • Lead strategy for aseptic processing simulation program at Juno
  • Collaborate with key partners (MFG, Training and QC micro) on holistic approach to aseptic

controls
  • Develop policy to for an innovative APS program, incorporating industry best practices and

ensuring compliance with regulatory guidelines
  • Maintain APS documentation (protocols, reports, schedule) in compliance with policy.

Facilitate both regularly scheduled and change based simulation requalification
  • Provide Validation impact assessment for process and material changes
  • Defend aseptic processing programs in regulatory inspections
  • Implement risk assessment tools to ensure appropriate process controls
  • Contribute to qualification program for closed system implementation, including qualification

of dispensing operations (both manual and automated)
  • Develop and execute facility and equipment qualification protocols

Required Education: BS in engineering, biology or equivalent scientific discipline

Required Experience:

Basic Qualifications:
  • 7+ years relevant biopharmaceutical industry experience
  • 3+ years of manufacturing experience is strongly preferred
  • Training, certification in aseptic processing
  • Excellent written and verbal skills, ability to clearly define written requirements is essential
  • Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects

Preferred Qualifications:
  • Experience using ValGenesis software for validation document development and execution is preferred
  • Strong technical understanding of biopharmaceutical systems, materials, equipment, and aseptic processing techniques

About Us

COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.

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