Validation Specialist

hace 4 semanas

Santiago, Chile Veg Group A tiempo completo

Validation Specialist (Upstream Process Equipment) LL Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: CQV Specialist for Upstream Process Equipment The CQV Specialist for Upstream Process Equipment will be responsible for the commissioning and qualification of systems supporting cell culture operations in a cGMP biotechnology manufacturing environment. The role includes the development and execution of protocols for bioreactors, media preparation systems, and other upstream support utilities. The successful candidate will collaborate with cross-functional teams and ensure compliance with FDA, EMA, and ICH regulatory requirements throughout the CQV lifecycle. Key Responsibilities: Author, review, and execute commissioning and qualification protocols (IQ, OQ, PQ) for upstream equipment. Perform field inspections, verification activities, and system walkdowns. Support FAT/SAT execution with equipment vendors and engineering teams. Ensure systems are installed, configured, and performing according to URS, FS, and DS documentation. Troubleshoot equipment and resolve discrepancies or deviations during commissioning and qualification. Maintain traceability between user requirements, functional/design specifications, and testing protocols. Interface with automation, process engineering, QA, and manufacturing to drive schedule adherence and quality. Prepare and review summary reports, risk assessments, and impact assessments as part of the validation package. Upstream Equipment in Scope: Single-use and stainless‑steel bioreactors (SUB/SSB). Media preparation tanks and skids. Cell culture incubators. Control systems for temperature, pH, DO, agitation, and gas flow. Seed train and expansion vessels. Sterile filtration skids. Clean utilities interfacing with process systems (WFI, clean steam, process air). Qualifications: Bachelor’s degree in engineering, biotechnology, or related science field. 3–7 years of CQV experience in a biopharma GMP environment, with specific focus on upstream process systems. Proficiency in authoring and executing validation protocols, and working within electronic systems (e.g., Valgenesis, Kneat). Familiarity with industry regulations including FDA, EMA, ICH Q8–Q10, and ASTM E2500. Strong technical understanding of upstream biotechnology processes and associated automation platforms. Preferred Skills: Experience with single-use technology (e.g., Sartorius, Thermo Fisher, Pall). Working knowledge of DeltaV or other process control systems. Exposure to tech transfer or facility startup projects in GMP settings. #J-18808-Ljbffr

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