Senior Validation Engineer

Overview

This position is responsible for planning, executing, and documenting commissioning, qualification, and validation (CQV) activities to ensure all systems meet stringent regulatory and client-specific requirements. The Senior Validation Engineer will act as a subject matter expert, collaborating closely with cross-functional teams, including Manufacturing, Facilities, Quality Control and Quality Assurance to deliver robust validation strategies that enable compliant and efficient operations in an early-phase clinical environment.

• Independently understanding quality standards, cGMP's, and regulatory standards to support team in compliance of validation effort.
• Authoring, editing, and executing technical commissioning, qualification and validation documentation for facilities, utilities, and standard equipment/systems/software.
• Actively consult clients on regulatory validation processes and standard industry acceptable practices.
• Collaborate with cross-functional teams including Manufacturing, Facilities, Quality Control and Quality Assurance to ensure validation activities are properly scoped and executed.
• Ability to take independent leadership role on project(s).
• Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis.

• Bachelor's degree in engineering, Life Sciences, or a related field.
• + years of relevant experience in validation within a regulated industry (, pharma, biotech).
• Experience with facility, utility, equipment, and computer system validation. Preferably in start-up of early-phase clinical biomanufacturing facilities.
• Strong knowledge of validation principles, cGMP, FDA regulations ( CFR Part , Part /), and industry guidelines (, ISPE, GAMP).
• Experience working with start-up clients, without well established company procedures and standards.
• Excellent documentation, analytical, and problem-solving skills.
• Ability to work independently and as part of a team