CQV ENGINEER

You will help create, organize, execute, and close out commissioning and qualification documentation that supports clinical manufacturing operations. The position will emphasize generation and execution of IQ/OQ/PQ protocols, commissioning activities, discrepancy and deviation management, coordination with system owners and vendors, and close collaboration with Engineering, Manufacturing, Quality, Facilities, and Operations teams. Day to day responsibilities Generate, review, revise, and execute CQV documentation, including User Requirements Specifications (URS), Risk Assessments, Impact Assessments, Requirement Traceability Matrices (RTMs), Commissioning Protocols, IQ/OQ/PQ protocols, discrepancy documentation, and summary reports. Execute commissioning and qualification protocols in the field for GMP manufacturing equipment, utilities, laboratory equipment, computerized systems and related support systems. Support the protocol lifecycle from drafting and routing through execution, data review, discrepancy resolution, report generation, and closeout. Support facility startup and commissioning activities, including system walkdowns, turnover package review, P&ID verification, punch list management, component verification, operational readiness, and field coordination. Conduct or support risk assessments and impact assessments, establish or document system boundaries, and translate assessment outputs into practical CQV deliverables under appropriate technical and Quality oversight. Author, review, and revise standard operating procedures, work instructions, and supporting GMP documentation as needed. Investigate, document and support the resolution and closeout of discrepancies and deviations, including impact assessment, corrective actions, and retest activities as appropriate. Coordinate with Engineering, Manufacturing, Quality, Facilities, Operations, system owners, and external vendors to plan execution windows, resolve field issues, and drive assigned deliverables to completion. Own defined CQV deliverables, equipment packages, or execution workstreams commensurate with experience, with guidance from senior technical and Quality team members. Education, Experience and Knowledge Requirements Bachelor’s degree in engineering, life sciences, or an equivalent technical discipline preferred. 2–5 years of experience in commissioning, qualification, CQV, manufacturing, engineering, facilities, operations, quality, or another GMP technical role; candidates with direct hands‑on CQV execution experience are strongly encouraged to apply. Experience in clinical manufacturing, start‑up, or early‑stage biopharmaceutical environments is a plus, particularly where responsibilities included both documentation and field execution. Hands‑on technical experience involving manufacturing equipment, utilities, process systems, laboratories, computerized systems, temperature‑controlled units, or GMP documentation is valued. Strong technical writing skills with the ability to produce clear, accurate, inspection‑ready protocols, forms, reports, SOPs, and supporting documentation. Comfortable performing hands‑on protocol execution, including observing equipment operation, recording data, following procedures, coordinating with system owners, and escalating issues appropriately. Experience with facility startup, commissioning, system turnover, P&ID walkdowns, field verification, punch list closure, vendor startup activities, and GMP readiness is preferred. Experience with Computer System Validation (CSV) and knowledge of FDA 21 CFR Part 11 compliance, data integrity requirements, and GxP computerized systems is preferred. Familiarity with GMP documentation practices, ALCOA principles, change control, discrepancy/deviation documentation, impact assessment, and qualification lifecycle concepts preferred. Basic understanding of FDA, EU GMP, ISPE, PDA, ICH, or other industry guidance is a plus. Strong attention to detail, organization, communication, follow‑through, and flexibility in a fast‑paced project environment. Compensation and Additional Information This is a full‑time, on‑site position located in Thousand Oaks, California, and requires working on‑site Monday through Friday. All applicants must be authorized to work in the United States. We are not sponsoring employment visas. Compensation: The salary range for this position is $70,000-115,000 . This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location. 20BLOC is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or other applicable legally protected characteristics. We offer competitive compensation and benefits including health, dental, vision and life insurance, 401(k) and paid time off. 1280 Rancho Conejo Blvd , Thousand Oaks, CA 91320 20BLOC INC. | 2023 | All Rights Reserved #J-18808-Ljbffr