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Sr. Validation Engineer

Quality Assurance | Research Triangle Park, NC | Full Time

Job Description

About Us:

Humacyte's mission is to become the leading company in novel, off-the-shelf extracellular matrix tissue products, and especially those that could provide lifesaving improvements in treatments for vascular conditions.

Humacyte, Inc., a biotechnology pioneer, discovers, develops and delivers innovative, award winning human biotherapies.  We are currently developing multiple vascular tissue engineered therapies and expanding our business model.  With a broad pipeline of potential new therapy applications, we continue to build our organization and scientific teams.

Responsibilities:

  • The Sr. Validation Engineer would be responsible for ensuring that processes and systems such as those associated with facilities, equipment, cleaning and analytical instrumentation are fully qualified and performing as designed 

  • Developing, recommending, and executing validation strategies to provide documented evidence that a processes, systems, equipment, cleaning, and software have been commissioned, qualified and/ or validated in a manner that meets or exceeds regulatory and cGMP requirements for GMP manufacturing operations

  • Support the validation program by writing, executing or providing oversight for detailed protocols and reports to document the validation of systems, equipment, and instrumentation associated with supporting GMP manufacturing operations in compliance with the appropriate regulatory agency validation requirements

  • Provide validation oversight for all relevant projects and will develop and implement solutions to validation related issues. This oversight includes but is not limited to new equipment onboarding, cleaning processes used in manufacturing and the utilities, change control, periodic review, and deviation management

  • Provide direction, support, and oversight for contract validation resources

Requirements:

  • BS in Engineering, Chemistry, Biology or other related scientific discipline
  • Five to ten years’ experience as a validation professional

  • At least five years of experience in the pharmaceutical industry preferred

  • The position requires independent performance and the ability to identify validation requirements, manage their time, handle multiple projects simultaneously and analyze and resolve the unique situations presented by Biological manufacturing

Bonus Points:

  • Knowledge of current industry expectations of validation requirements for process validation, cleaning validation, computer validation, and equipment qualification; knowledge of all current cGMP requirements in the US and other parts of the world

  • Ability to handle multiple projects and deliver on aggressive project timelines with little supervision

  • Ability to determine, present, and defend in a professional manner project requirements/status

  • Ability to communicate clearly to all levels (operator to senior management) within the site

  • Must be able to utilize Microsoft Office

  • Understanding of statistical evaluation tools

  • Experience leading and directing validation resources

  • Adhere to all Humacyte Quality Management System (QMS) policies and procedures as applicable for functional area

  • Strictly comply with all cGMP guidelines

Perks:

  • Stock Options
  • 401k Plan with Matching
  • Medical, Vision and Dental Plans
  • Long Term/Short Term Disability
  • Life Insurance
  • 3 Weeks’ Vacation
  • 5 Personal Floating Days
  • 8 Sick Days
  • 6 Company Holidays
  • Career Development and Training