Senior/Principal Equipment Engineer - Spray Drying
2 days ago
Paterna
At Bionanopharma, we are looking for a Senior/Principal Equipment Engineer – Spray Drying to join our Operations team. This is a unique opportunity for a senior engineering professional to become the technical authority for spray drying systems, playing a key role in the design, qualification, implementation, and lifecycle support of critical equipment in a GMP-regulated environment. • Define and own the architecture of spray drying systems across laboratory, pilot, and commercial scales., • Lead the selection and specification of critical equipment components, including atomizers, nozzles, feed pumps, tubing, valves, seals, drying chambers, cyclones, bag filters, exhaust systems, powder collection, discharge, and containment hardware., • Evaluate materials of construction (stainless steel grades, elastomers, coatings) ensuring GMP compliance, cleanability, chemical compatibility and long‑term durability., • Review and approve BOMs, P&IDs, mechanical drawings and layout designs., • Lead or support mechanical design reviews, HAZOP studies and equipment‑focused risk assessments., • Define utilities and infrastructure requirements, including HVAC, compressed air, nitrogen, steam, CIP/SIP and electrical systems., • Ensure robust integration of spray drying equipment with facility systems and containment solutions., • Support capital projects, equipment installation, site acceptance activities., • Lead and/or approve qualification activities, including DQ, IQ, OQ and PQ., • Define Critical Equipment Parameters (CEPs) and ensure full traceability to user requirements and risk assessments., • Ensure equipment design and operation meet GMP, data integrity and regulatory expectations., • Support audits, inspections and regulatory submissions related to equipment design and validation., • Act as the main technical interface with spray dryer manufacturers, component suppliers, engineering firms and system integrators., • Lead FAT/SAT planning and execution, including protocol review and acceptance criteria definition., • Manage technical aspects of change controls, deviations and CAPAs related to equipment., • Support procurement, installation, commissioning and long‑term equipment lifecycle management., • Provide advanced troubleshooting during GMP manufacturing campaigns., • Lead root‑cause investigations for equipment‑related failures and performance issues., • Drive continuous‑improvement initiatives focused on reliability, maintainability and compliance., • Establish and maintain equipment standards, spare parts strategies and preventive maintenance requirements., • MSc or PhD in Mechanical Engineering, Chemical Engineering, Pharmaceutical Engineering or related discipline., • 10+ years of experience in equipment engineering roles within regulated environments., • Experience in spray drying equipment design, specification, component selection and qualification/validation., • Experience working in GMP manufacturing environments (strong plus)., • Fluent in English and Spanish., • Deep understanding of: spray dryer mechanical design and airflow systems; powder handling, containment and CIP; instrumentation, automation interfaces and control systems from an equipment perspective., • Hands‑on experience with commercial spray drying platforms and custom‑built systems., • Working knowledge of GMP and ICH guidelines relevant to equipment (asset)., • Strong problem‑solving skills, organization, persistence and autonomy., • Ability to work independently, prioritize effectively and meet project timelines., • Strong self‑motivation and ability to motivate others., • Ability to thrive in a fast‑paced environment and manage multiple competing priorities., • Opportunity to make a real impact in a highly specialized and strategic engineering role., • Exposure to challenging projects linked to equipment design, scale‑up, validation and commercial manufacturing., • Technically demanding and innovation‑driven environment focused on quality and operational excellence., • Initial contact with the Talent Acquisition team., • Interviews with Talent Acquisition and the Hiring Manager., • Possible additional step to assess technical fit for the role., • Continuous communication throughout the process. At Bionanopharma, we are committed to building an inclusive workplace based on equal opportunities and respect. All applications will be considered regardless of gender, gender identity or expression, sexual orientation, age, marital status, ethnic or social origin, nationality, religion, disability or any other characteristic protected by applicable law. #J-18808-Ljbffr