Validation Engineer

Kriya is a next generation gene therapy company focused on expanding the field to new frontiers. We have built a fully integrated, technology enabled platform for rational vector design, analytical characterization, and scalable manufacturing to design and develop gene therapies for diseases with well-understood underlying biology. We believe that rationally engineered gene therapies can transform the treatment of a broad universe of diseases – and we are prepared to lead this revolution in medicine.

Our team is made up of leading scientific experts who are passionate about improving patients’ lives and easing the burden of these life-changing disorders for patients. We are looking for teammates with the ambition, creativity, and energy to help us build a unique organization.

If you are looking to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, Kriya is the company for you.

Position Summary:

Kriya Therapeutics in Morrisville, NC is looking for a Validation Engineer to support the startup and ongoing operations of our GMP manufacturing facility. This engineer will lead and manage efforts to commission, qualify, and requalify equipment and instruments throughout the facility.

• Represents Validation department on project teams
• Leads commissioning, qualification, and validation activities 
• Authors relevant documentation such as SOPs, User Requirements Specifications, protocols, requirements trace matrices, and summary reports
• Provides ongoing support for equipment throughout the system lifecycle including revalidation, troubleshooting, and deviation management
• Assists with designing, specifying, procuring, and installation of manufacturing, laboratory, facility, and utility equipment and systems
• Assists with maintenance and calibration activities
• Coordinates with external vendors and consultants

Required Qualifications:

• Bachelor of Science degree in Engineering, Science, or related field.
• 3-5 years of relevant experience in gene therapy/biotechnology/pharmaceuticals
• Highly self-motivated and detail-oriented, with proven ability to foster strong relationships with other team members and stakeholders
• Experience with commissioning and qualification lifecycle documentation and activities  
• Strong technical writing and oral communication skills
• Excellent interpersonal and organizational skills with strong attention to detail

• Good customer/client relationship management and proactive problem-solving skills. 

Working Conditions:

• Work is normally performed onsite in an office, laboratory, or manufacturing environment
• Physical requirements:
  1. Ability to stand for extended hours
  2. Ability to lift objects up to 25 pounds
  3. Ability to climb ladders/steps
• Less than 5% of travel required

Kriya is an equal opportunity employer. 

We celebrate diversity and are committed to creating an inclusive environment for all employees.