Principal Equipment Engineer - Spray Drying Specialist
18 hours ago
Valencia
Job Title: Principal Equipment Engineer - Spray Drying Specialist Location: Valencia, Spain Applications to be sent to: Department Operations Position Summary We are seeking a senior-level equipment-focused engineer, ideally in a pharma environment, to serve as the technical authority for spray drying systems, with primary responsibility for equipment architecture, component selection, mechanical and systems engineering, qualification, and lifecycle support in GMP-regulated environments. This role is dedicated to hardware, utilities, automation interfaces, and validation, ensuring that spray drying systems are fit-for-purpose, compliant, and scalable, from vendor design through routine commercial operation. Key Responsibilities Equipment Architecture & Part Selection Define and own spray drying system architecture across lab, pilot, and commercial scales. Lead selection and specification of critical equipment components, including: Atomizers and nozzles Feed pumps, tubing, valves, and seals Drying chambers, cyclones, bag filters, and exhaust systems Powder collection, discharge, and containment hardware Evaluate materials of construction (e.g., stainless steel grades, elastomers, coatings) for GMP compliance, cleanability, chemical compatibility, and durability. Approve equipment BOMs, P&IDs, mechanical drawings, and layout designs. Mechanical, Utilities & Systems Engineering Lead or support mechanical design reviews, hazard and operability studies and risk assessments from an equipment perspective. Define utilities and infrastructure requirements (HVAC, compressed air, nitrogen, steam, CIP/SIP, electrical). Ensure proper integration of spray drying equipment with facility systems and containment solutions. Support capital projects, equipment installation, and site acceptance activities. Qualification, Validation & Compliance Lead and/or approve equipment qualification activities (DQ, IQ, OQ, PQ) for spray drying systems. Define critical equipment parameters (CEPs) and ensure 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. Supplier and Project Management Act as primary technical interface with spray dryer manufacturers, component suppliers, engineering firms, and integrators. Lead FAT/SAT planning and execution, including review of test protocols and acceptance criteria. Manage technical aspects of change control, deviations, and CAPAs related to equipment. Support procurement, installation, commissioning, and long-term equipment lifecycle management. Manufacturing & Lifecycle Support Provide advanced equipment troubleshooting during GMP manufacturing campaigns. Lead root cause investigations for equipment-related failures or performance issues. Drive continuous improvement initiatives focused on reliability, maintainability, and compliance. Establish and maintain equipment standards, spare part strategies, and preventive maintenance requirements. Required Qualifications Education MSc or PhD in Mechanical Engineering, Chemical Engineering, Pharmaceutical Engineering, or related discipline Experience 10+ years of experience in regulated equipment engineering roles. Demonstrated leadership in: Spray drying equipment design and specification Component and part selection Equipment qualification and validation Experience working in GMP manufacturing environments will be an added value. Languages: Fluent English and Fluent Spanish. Personal skills: Resolution, good organizational skills, persistency and autonomy. Able to work independently, prioritize and meet project timelines, be strongly self-motivated and able to motivate a team. Ability to work in a fast-paced environment and manage multiple competing demands. Technical Expertise Deep understanding of: Spray dryer mechanical design and airflow systems Powder handling, containment, and clean-in-place (CIP) Instrumentation, automation interfaces, and control systems (from an equipment standpoint) Hands-on experience with commercial spray drying platforms and custom-built systems. Working knowledge of GMP and ICH guidelines relevant to equipment will be an added value.