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Senior Validation Engineer

All Openings | Research Triangle Park, NC | Full Time

Job Description

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.  We are looking for additional colleagues to continue to build our expanding team.

Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.

Position Background:

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

Primary Responsibilities:

  • Responsible for developing, recommending, and executing validation strategies to provide documented evidence that facilities, equipment, system, cleaning methods, and analytical instrumentation 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 protocols and reports documenting the validation of facilities, equipment, system, cleaning methods, and analytical instrumentation
  • Provide oversight and lead projects requiring validation, which includes, but not limited to, new equipment, systems, cleaning processes, and analytical instrumentation, change control, periodic review, and deviation management  
  • Provide direction and support for contract validation resources
  • Collaborate with external resources for equipment, systems, cleaning processes, and analytical instrumentation, change control, periodic review, and deviation management 
  • Develop, create, update and edit SOP’s for validation processes, as needed
  • Other duties, as assigned

General Competencies:

  • Able to communicate effectively in English, both verbally and in writing
  • Possess a positive roll-up-the-sleeves attitude and optimistic outlook
  • Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
  • Excellent organizational and time management skills with ability to set own priorities in a timely manner
  • High degree of flexibility and adaptability
  • Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
  • Must be able to work as needed to meet tight deadlines and at peak periods
  • Self-motivated and organized critical thinker with solid interpersonal and business communication skills
  • Demonstrated ability to work in a cross functional team
  • Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
  • Always observe safety precautions and regulations in all areas where duties are performed. Responsible for reporting all safety hazards and potential unsafe working conditions
  • Represents the organization in a positive and professional manner.
  • Reports to work on time and as scheduled

Special Competencies:

  • Ability to handle multiple projects and deliver on aggressive project timelines with little supervision
  • Ability to establish, manage, and present, in a professional manner validation project requirements and status
  • Ability to communicate clearly to all levels within the organization
  • Understanding of statistical evaluation tools
  • The position requires independent performance, time management, manage multiple validation projects simultaneously, and analyze and resolve the unique compliance needs presented by Humacyte Bioprocessing
  • Works as a team player, and serves as a model by participating in activities that involve cooperating with others

QUALIFICATIONS:

  • Bachelor's degree
  • 8+ years' experience as a validation professional
  • At least five years of experience in the pharmaceutical industry, preferred
  • Experience leading and directing validation resources 
  • Knowledge of cGMP requirements in the US and EU, required
  • Knowledge of current industry expectations of validation requirements for process validation, cleaning validation, computer validation, and equipment qualification, required
  • Will spend a portion of time in clean room environment to perform validation activities and will be required to meet applicable gowning and personal protective equipment guidelines

Perks:

  • Stock Options
  • 401k Plan with Matching
  • Medical, Vision and Dental Plans
  • Long Term/Short Term Disability
  • Life Insurance
  • 23 Days Paid Time Off (PTO)
  • 11 Paid Holidays
  • Paid Parental Leave Policies

**Please note, Humacyte does not provide sponsorship at this time.**