Quality Engineer II

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 Quality Engineer II assists in developing quality policies and provides support to the overall technical aspects of the Quality Assurance program at the site. Ensures manufacturing operations are within cGMP and GTP regulations and company procedures.

This position reports to Director, Quality Assurance

Major Accountabilities:

• Ensure comprehensive understanding of the organizational objectives and identify how to translate those into strategies and tactics for implementation in Quality engineering

• Oversee and own a variety of Quality System or systems and act as a facilitator and administrator

• Design, continuously analyze and improve elements of the owned quality system

• Develop and maintain metrics and trending reports of the quality systems using a variety of statistical analysis tools.   Share analysis of data and trending reports with manager or other appropriate colleagues and develop recommendations for utilizing data effectively

• Lead and participate in in cause-identification and problem-resolution (CAPA) for varied, complex and atypical types of quality or manufacturing related issues

• Lead and participate in Root Cause Analysis teams. Collaborate with individuals performing investigations to ensure the process is handled with the appropriate level of detail

• 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 writing, review, and approval of Change Controls

• Utilizing advanced technical quality engineering skills, collaborate in the design, fabrication, development, installation, validation, and qualification of equipment / processes/ systems

• Research appropriate methods, plan and implement quality related projects to develop, install, and qualify new processes for manufacturing new products or improving existing processes

• Ensure that validation and qualification activities are consistent with company validation policies and procedures and federal regulations

• Evaluate and update existing SOP’s for cGMP compliance and compliance to corporate policies and procedures

• Represent quality function on project teams as an engineering subject matter expert, with the objective to assure that departmental quality objectives are met

• Participate in team meetings related to changes in processes, process improvements and provide suggestions as needed

• Provide coaching and training and guidance on aspects of quality roles within the validation process

• Contributes to the development, implementation and execution of quality systems programs, as required

• Other duties, as assigned
  
  

Special Competencies:

• Excellent written and oral communication skills and the ability to influence and generate buy in through communication skills and advanced expertise
• Advanced understanding of Validation strategies and the ability to write validation protocols and reports
• Excellent problem solving, decision-making ability, and interpersonal skills that enables conflict resolution as related to technical situations is desired
• Ability to resolve processing challenges within manufacturing through expertise, collaboration and influencing
• Proficient with Microsoft Office, preferred
• Detailed oriented, self-motivated and scientifically driven
• Demonstrated ability to work in a cross functional team

General Competencies:

• Able to communicate effectively in English, both verbally and in writing

• Possess a positive roll-up-the-sleeves attitude and optimistic outlook

• Represents the organization in a positive and professional manner

• 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

• Reports to work on time and as scheduled

QUALIFICATIONS:

• Bachelors or Master’s Degree in Chemical Engineering, Biomedical Engineering, Biology or Chemistry
• 5-8 years of pharmaceutical work experience, preferably in medical devices or biologics
• Process Excellence training
• Strong understanding of cGMP, ISO and ICH guidance’s in the biotech manufacturing environment
• Demonstrated background in support of GMP Quality management systems
• Experience executing validations plans and reviewing and writing validation protocols, reports and technical documents.
• Experience in evaluating technical quality problems and providing recommendations for corrective actions
• Firm understanding of Quality Management Systems processes and the ability to lead investigations.
• ASQ certification , a plus
• Experience conducting Process / Design Failure Mode Effects and Analysis, preferred
• Familiarity with inspection methods and techniques, preferred

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)
• 12 Paid Holidays
• Paid Parental Leave Policies

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