Senior Engineer, Validation

Key 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.

Skills, Knowledge & Expertise

• 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.).
• Experience with the Kneat Gx software is a plus.

• Primarily desk-based, generally in an office or home office setting.
• May involve extended periods of sitting and computer use.
• May involve standing, sitting, and using manufacturing equipment for extended periods.
• Some lifting of equipment or materials may be required.
• Work may involve exposure to chemicals or biological materials.
• Occasional travel may be required.

Benefits

• Time Off & Work-Life Balance: Flexible Time Off ∙ Paid Parental & Medical Leave ∙ Paid Company Holidays
• Health & Wellness: Fertility & Family Building Benefits ∙ Medical, Dental, and Vision Insurance ∙ Employee Assistance Program (EAP) ∙ Life Insurance ∙ Short- and Long-Term Disability Coverage
• Financial Security: Equity ∙ 401(k) with Company Match ∙ Identity Theft Protection
• And More!