Senior Engineer, Validation

Kriya Therapeutics•Durham, NC

7d•Onsite

About The Position

Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world. We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology. We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of BioSpace’s “2025 Best Places to Work.”

Requirements

Bachelor's degree or higher in a scientific or engineering discipline (e.g., Biology, Chemistry, Biotechnology, Chemical Engineering, or related field).
6-8+ years of experience in validation and qualification of GMP equipment and facilities within the biotech or pharmaceutical industry.
Solid working knowledge of EU and FDA regulations and guidelines pertaining to GMP equipment and facility validation and qualification.
Demonstrated experience authoring and executing validation protocols, including data analysis and report generation.
Working knowledge of risk assessment methodologies and their application to validation activities.
Strong interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams and external partners.
Detail-oriented mindset with strong analytical and problem-solving abilities.
Familiarity with GMP drug substance and drug product manufacturing, cleanrooms, utilities (HVAC, clean gas systems, etc.), and critical systems (process equipment, automation systems, etc.).

Nice To Haves

Experience with the Kneat Gx software is a plus.

Responsibilities

Independently develop validation approach supporting complex validation projects for GMP equipment, facilities, utilities, and critical systems in line with EU and FDA requirements.
Execute the validation lifecycle, including authoring validation project plans, protocol development (IQ/OQ/PQ), test execution, data analysis, and report generation for equipment, facilities, utilities, and critical systems, ensuring adherence to approved procedures and timelines.
Support development, execution, and continuous improvement of the Kriya validation strategy and roadmap in partnership with Validation leadership.
Maintain validation policies, procedures, and best practices to ensure compliance with GMP regulations.
Collaborate closely with cross-functional teams, including Manufacturing, Quality Assurance, Quality Control, Engineering, Facilities, Regulatory Affairs, Operational Technology, and Computer System Validation, to support alignment and coordination of validation activities.
Conduct risk assessments and develop validation plans based on the criticality and complexity of equipment and systems.
Coordinate with external vendors, contractors, and consultants for equipment and facility validation projects, as necessary.
Review GMP documentation, such as protocols, reports, and deviations, authored by peers for accuracy, completeness, and compliance with regulatory requirements.
Stay up-to-date with EU and FDA regulations, guidelines, and industry best practices related to GMP equipment and facility validation, and recommend updates to ensure ongoing compliance.
Participate in ongoing quality processes as needed, including drafting and reviewing CAPAs, Change Controls, Periodic Reviews, Policies, Procedures, and Deviations.
Support internal and external regulatory inspections as a Validation SME, taking ownership of any responses and resulting corrective actions.
Provide technical guidance and mentorship to junior validation engineers and technicians, as needed.