Validation Engineer

We are seeking experienced Validation Engineer to support documentation development and execution for an equipment replacement and process upgrade project at a large-scale biologics manufacturing facility. This role involves authoring and executing cleaning validation protocols within a modern electronic validation system while collaborating with Quality Assurance, subject matter experts, and cross-functional technical teams. This is an excellent opportunity for a hands‑on validation professional to work with large-scale biologics manufacturing equipment and electronic validation systems in a structured project environment. Key Responsibilities: Author cleaning validation protocols for new and modified cleaning processes using an electronic/paperless validation system. Execute cleaning validation protocols, including sampling, data collection, and documentation. Support discrepancy investigations, punch list resolution, and retesting activities as required. Prepare and support cleaning validation reports and project closeout documentation. Collaborate with Quality Assurance, subject matter experts, and technical teams throughout document review and execution cycles. Ensure compliance with cGMP requirements, data integrity standards, and validation procedures. Support equipment replacement and process upgrade validation activities. Required Qualifications: Hands‑on experience authoring and/or executing cleaning validation protocols in a cGMP pharmaceutical or biotechnology manufacturing environment. Strong technical writing skills with experience preparing cGMP documentation. Bachelor's degree in Engineering, Life Sciences, or a related field, or equivalent hands‑on industry experience. Ability to work onsite during the execution phase. Preferred Qualifications: Experience with CIP/SIP systems, bioreactors, centrifuges, or similar bioprocess equipment. Experience using Kneat GxP or other electronic/paperless validation systems. Experience in biologics or large molecule manufacturing facilities. Experience supporting equipment replacement, process upgrades, or technology transfer projects. #J-18808-Ljbffr Novozen Healthcare LLC