Senior CQV Engineer

Job Summary

• The Senior CQV Engineer will play a critical role in the successful startup and qualification of a new early-phase clinical biomanufacturing facility, encompassing clean rooms, utilities, and a wide range of systems and equipment.
• 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.

• Authoring, editing, and executing technical commissioning, qualification and validation documentation for facilities, utilities, and standard equipment/systems/software.
• Actively consulting clients on regulatory validation processes and standard industry acceptable practices.
• Collaborating with cross-functional teams including Manufacturing, Facilities, Quality Control and Quality Assurance to ensure validation activities are properly scoped and executed.
• Taking 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 – including 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.