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
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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.