Process Engineer

SUMMARY:

Kriya Therapeutics in Morrisville, NC is looking for a Process Engineer to support the startup of our GMP manufacturing facility. This engineer will lead and manage efforts to design, procure, onboard, validate, and maintain equipment throughout the facility. The Process Engineer will support the initial startup and qualification of the GMP facility as well as future projects for optimization and tech transfers.

RESPONSIBILITIES:

• Represents Engineering & Facilities department on project teams
• Designs, specifies, procures, and installs manufacturing, laboratory, facility, and utility equipment and systems
• Leads commissioning, qualification, and validation activities
• Provides ongoing support for equipment throughout the system lifecycle including troubleshooting and deviation management
• Authors relevant documentation such as specifications, protocols, and SOPs
• Manages maintenance and calibration activities
• Coordinates with external vendors and consultants

REQUIREMENTS:

• Bachelor of Science degree in Engineering, Science, or related field.
• 3-5 years of relevant experience in gene therapy/biotechnology
• 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:
o Ability to stand for extended hours
o Ability to lift objects up to 25 pounds
o Ability to climb ladders/steps
• Less than 5% of travel required

This is an exciting time to participate in the field of gene therapy in general, and to become a part of Kriya Therapeutics’ fast-growing dedicated team. Kriya Therapeutics offers an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.