Process Engineer (Spray Drying)

At ESTEVE, we are looking for a Senior Production Specialist – Spray Drying to join our manufacturing organization. This is a key role within our production plant, responsible for ensuring the successful execution, industrialization, and optimization of Spray Drying processes. You will lead continuous improvement initiatives, drive process robustness and scale-up activities, and ensure compliance with the highest GMP and quality standards while acting as the technical reference for Spray Drying technology.

Mission:

To ensure the successful industrialization, validation, and implementation of new Spray Drying processes, guaranteeing technical robustness, GMP compliance, and customer satisfaction. The role acts as the technical reference and Process Owner for the Spray Drying area, working closely with customers and cross-functional internal teams.

Key Responsibilities:

Process Industrialization & Technical Leadership

• Lead the industrialization of new Spray Drying processes, from advanced development stages through commercial manufacturing.
• Act as the site's technical expert for Spray Drying processes, ensuring scalability, robustness, reproducibility, and successful technology transfer.
• Participate in the definition and optimization of Critical Process Parameters (CPPs) and support Design of Experiments (DoE) and Quality by Design (QbD) studies when applicable.
• Provide technical oversight during manufacturing campaigns, investigating process deviations and driving corrective actions and continuous improvement initiatives.
• Act as Process Owner for Spray Drying technologies within the organization.

Customer Relationship & Project Management

• Serve as the primary technical point of contact for customers on all Spray Drying-related matters.
• Lead and provide technical support during customer visits, audits, and technical meetings.
• Act as a key member of project core teams, representing the Spray Drying area from project initiation through process validation and commercial implementation.
• Ensure customer requirements are accurately translated into robust and compliant industrial processes.

Industrial Equipment Management

• Lead the technical optimization of existing Spray Drying lines, acting as the Subject Matter Expert (SME) for production and process-related activities.
• Drive improvements in operational efficiency, capacity, process robustness, and flexibility to accommodate new products and customer requirements.
• Participate in new installations, capacity expansions, and equipment upgrades, collaborating closely with Engineering teams on design, qualification, and implementation activities.

Documentation & GMP Compliance

• Prepare, review, and approve technical and GMP documentation related to process industrialization, including Change Controls, Master Batch Records, Validation Protocols and Reports, Manufacturing Recipes, Quality Risk Assessments (QRAs), and Risk Assessments.
• Lead and/or support investigations and closure of deviations, CAPAs, and Change Controls associated with production campaigns and newly implemented processes.
• Ensure compliance with GMP requirements, Data Integrity principles, Health & Safety standards, and environmental regulations across all activities.

Internal Coordination & Training

• Collaborate effectively with Production, Engineering, Quality Assurance, Validation, Supply Chain, and Project Management teams to ensure successful project execution.
• Provide technical guidance and training to operations personnel and internal stakeholders on Spray Drying processes and best practices.
• Promote knowledge sharing and continuous development within the organization.

Continuous Improvement & Technology Development

• Identify and implement process optimization opportunities to improve product quality, efficiency, yield, and operational excellence.
• Support the evaluation and implementation of new technologies, tools, and methodologies related to Spray Drying.
• Contribute to the site's innovation and continuous improvement strategy.

Required Qualifications & Experience:

• Bachelor's Degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline.
• Proven experience in process industrialization, scale-up, technology transfer, and process validation.
• Strong knowledge of GMP regulations and pharmaceutical manufacturing environments.
• Professional proficiency in English (written and spoken).
• Minimum of 2 years of experience in the production of APIs and/or pharmaceutical intermediates within the pharmaceutical or chemical industry.
• Previous experience leading production teams and coordinating cross-functional stakeholders.

What We Offer:

• Direct employment contract with a growing and expanding pharmaceutical company.
• Flexible working hours.
• Hybrid working model.
• The opportunity to play a key role in strategic industrialization, technology transfer, and continuous improvement projects within a dynamic and innovative manufacturing environment.
• Career development opportunities in a global, values-driven organization committed to improving people's lives.