Senior GMP Validation Engineer – Equipment & Facilities

Kriya Therapeutics, Inc.; Morrisville (NC); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Flexible Time Off

Medical, Dental, Vision Insurance

401(k) with Company Match

Life Insurance

Job summary

Kriya Therapeutics, Inc. is seeking a Senior Engineer, Validation to lead and execute a robust validation program for our GMP manufacturing facility in Research Triangle Park, NC.

You will develop validation plans, author IQ/OQ/PQ protocols, and drive compliant execution with cross-functional partners. Ideal candidates have 6–8+ years of validation experience in biotech/pharma, strong regulatory knowledge, and a collaborative, detail-oriented mindset to support lifecycle validation and

Qualifications

• Bachelor’s degree in a scientific or engineering discipline.
• 6–8+ years of validation and qualification experience in biotech/pharma.
• Solid knowledge of EU and FDA GMP validation guidelines.
• Experience authoring/executing validation protocols including IQ/OQ/PQ.
• Strong collaboration across multiple functions and vendors.

Responsibilities

• Develop validation approaches for GMP equipment, facilities, utilities, and critical systems.
• Author validation project plans, IQ/OQ/PQ protocols, and execution reports.
• Analyze data, ensure compliance, and generate final reports on time.
• Maintain and improve validation policies, procedures, and best practices.
• Collaborate with Manufacturing, QA, QC, Engineering, Facilities, Regulatory Affairs, and OT.
• Mentor junior validation engineers and technicians.

Skills

GMP validation

Equipment validation

Regulatory compliance

Cross-functional collaboration

Risk assessment

Technically proficient

Education

Bachelor’s degree in a scientific or engineering discipline

Tools

Kneat Gx

Job description

Kriya Therapeutics, Inc. is seeking a Senior Engineer, Validation to lead and execute a robust validation program for our GMP manufacturing facility in Research Triangle Park, NC.

You will develop validation plans, author IQ/OQ/PQ protocols, and drive compliant execution with cross-functional partners. Ideal candidates have 6–8+ years of validation experience in biotech/pharma, strong regulatory knowledge, and a collaborative, detail-oriented mindset to support lifecycle validation and