What are the responsibilities and job description for the Senior CQV Engineer position at Katalyst CRO?
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 cleanrooms, 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
- Roles & Responsibilities:
- 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.
- Education & Experience :
- Bachelor's degree in engineering, Life Sciences, or a related field
- 5 years of relevant experience in validation within a regulated industry (e.g., 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 (21 CFR Part 11, Part 210/211), and industry guidelines (e.g., 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