Quality Assurance Engineer (Multiple Roles/Biotech Facility) – Top $$/Raleigh

Category: 
Life Sciences
Job Type: 
Life Sciences
Quality Assurance and Quality Control
Other Life Science Positions
Employment Category: 
Direct Hire

Our client, a rapidly-expanding biotechnology company that is building out its primary manufacturing facility in the North Raleigh area, is actively recruiting for several Quality Engineers to assume key roles on its Quality Assurance team. 

This is a gene therapy company with multiple products in development.  Building out a top-notch Quality group is essential at this time.  Company will pay generously to attract and retain the best.

Key things to note:

  • This is a global company that is developing immunotherapies for cancer treatment based on its patented gene editing technology
  • The North Raleigh facility will be cGMP compliant.
  • These Engineers will partner with MSAT, Manufacturing, and Validation to establish and maintain the new manufacturing facility and site procedures.  Roles will involve supporting:
    • qualification and validation for manufacturing equipment, instrumentation and facility design
    • manufacturing Change Controls, Investigations, and CAPAs
  • Familiarity with biologic or cell-based manufacturing processes will be important.
  • Positions will involve contributing to the establishment of facility Quality policies and procedures.  Seek candidates with the knowledge and ingenuity needed to thrive.

Responsibilities will include:

  • Provide quality engineering input in the design, development, installation, validation, and qualification of equipment / processes/ systems
  • Ensure that validation and qualification activities are consistent with company validation policies and procedures and site validation master plan
  • Assure appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures
  • Ensure method qualifications, method transfers, aseptic room qualification, environmental monitoring qualification and technical transfers meet company and regulatory requirements.
  • Lead and participate in root cause identification and resolution (CAPA) for various types of quality or manufacturing related issues
  • Review and approve investigation reports to ensure they contains the appropriate level of detail; and appropriate CAPA’s are identified
  • Oversee and participate in the Change Control process including the authoring, review, and tracking of Change Controls
  • Author and/or review SOPs for cGMP compliance and compliance to corporate policies and procedures
  • Represent Quality Assurance on project teams to assure that quality objectives are met

Client will hire several candidates to build this team, ideally with complementary skill sets.

Priorities include:

  • Related scientific or engineering degree and 3+ years of relevant experience in a biopharmaceutical company
  • Knowledge of current global initiatives including Quality by Design, Process Validation and Data Integrity
  • Familiarity with tests and techniques used for biologics including microbial load, microbial identification, endotoxin, sterility, cell culture, nutritional adequacy, aseptic technique, flow cytometry, ELISA, cell-based assays, potency testing, working in an isolator, cytometer, etc.
  • Ability to adapt Quality System elements to cell/gene manufacturing; biologics or related experience important
  • Understanding of aseptic manufacturing
  • Substantial experience with most of the following:
    • Equipment and instrument validation and qualification
    • Method development
    • Computer system validation
    • Change control, investigations and CAPAs
  • SOP writing and/or review

Finally and critically, we seek a collaborative, versatile and innovative doer; Someone who is eager and ready to contribute broadly to this emerging company doing life-saving work.

This is an immediate need.  Please forward Word resume for prompt consideration.  Local candidates only.