Principal Quality Engineer (Validation/Launches) – Emerging NC Biotech (Will Relo)

Job Type: 
Professional Services
Engineering
Quality Assurance and Quality Control
Other Professional Positions
Employment Category: 
Direct Hire

Our client, a North Carolina-based biotechnology company that is developing novel therapies for the treatment of various respiratory and other diseases, is actively recruiting for a very sharp and skilled Quality Engineer to lead Validation and other Quality Systems efforts.   

This is a critical role and company will pay industry-leading wage to attract and retain the right candidate.

Key Things to Note:

  • The company, which is combining its proprietary precision technology with new and established medicines, is preparing for its first commercial launch.  Experience with new product introductions would be valuable.
  • This position on-site at its Research Triangle Park, NC facility.  COVID vaccinations/boosters required. Relocation support is available.
  • Position will involve leading all validation and related activities for company products as well as products developed in partnership with other pharma/biotech firms.  Seek Quality Engineer who is accustomed to collaborating with R&D personnel and enjoys in an interactive role.
  • This is a start-up setting.  This Principal Quality Engineer will help to establish Quality/Validation practices and systems for the entire organization.  We seek a hands-on, industrious candidate who will thrive in this building environment.

Position will involve leading validation activities and providing technical oversight as well as ensuring compliance of Change Control, Maintenance and Calibration activities with company, FDA and other regulatory requirements.

Selected Duties:

  • Continuously evaluate and evolve company’s Validation Policy and Procedural level documents to ensure compliance with current regulatory (FDA, etc.) expectations
  • Create, revise, review and approve documentation in Quality Assurance systems including SOPs, Validation Plans and Protocols, Risk Assessments, Investigations, Change Controls, Deviations, and CAPAs.
  • Monitor and ensure compliance with Change Control, Maintenance and Calibration policies and procedures
  • Serve as subject matter expert on validation in support of partner and regulatory audits
  • Support/lead technical investigations
  • Perform internal systems and compliance audits, including supplier inspections
  • Partner seamlessly across departments to enable the team’s growth, development, and overall success.

Targeted candidate will offer a BS/MS scientific or technical degree and 7+ years of Quality experience in a cGMP-regulated setting.  Launch and/or NPI experience preferred.

Other priorities include:

  • Experience developing and executing validation strategies for clinical and commercial development
  • Experience in:
    • Validation (Risk Assessment, Gap Assessment, IQ, OQ, PQ, PV, CV, CSV, etc.)
    • Quality Systems (Change Control, Non-Conformances, Requalification, etc.)
    • Process Excellence Methodologies (Six-Sigma, Lean, etc.)
  • Outstanding project management skills
  • Keen analytical ability and problem-solving skill
  • Record of impact and growth

Finally, we seek an industrious and self-directed candidate who will be a significant contributor to this company that is doing innovative and impactful work; A candidate who can thrive without a roadmap and will bring the knowledge, savvy and drive to work through ambiguity and complexity to achieve desired results.

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