Experienced Quality Engineer (NPI/Validation) – RTP Biotech/Top $$

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 introductionswould be valuable.
• 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 an interactive role.
• This is a start-up setting.  This Quality Engineer will help establish Quality/Validation practices and systems for the entire organization.  We seek a hands-on, industrious candidate who will thrive in this building environment.
• This position on-site at its Research Triangle Park, NC facility. 

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
• 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
• Create, revise, review and approve documentation in Quality Assurance systems including SOPs, Validation Plans and Protocols, Risk Assessments, Investigations, Change Controls, Deviations, and CAPAs.
• 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 3+ years of increasingly responsible Quality roles in a cGMP-regulated setting.  Launch and/or NPI experience a plus.

Other priorities include:

• Experience developing and executing validation strategies for multiple phases of clinical and commercial development required in either biotechnology, pharmaceuticals, or medical device industries.
• 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.)
• Quality/validation experience in both outsourced and in-house manufacturing settings
• Strong 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.