Senior Manufacturing Specialist - Isolator Technology

About the role

PCI Pharma Services is looking for a Senior Manufacturing Specialist - Isolator Technology (permanent role) to join its team in Leon, Spain. It is a Monday to Friday position. The specialist acts as the technical expert for manufacturing operations, with particular expertise in aseptic filling and isolator technology, providing leadership and support for complex processes in line with FDA and other regulatory requirements.

Key responsibilities

• Ensure compliance with GMP, manufacturing procedures and regulatory standards, and resolve compliance issues with sustainable corrective actions.
• Serve as the site SME for aseptic filling and isolator technology, guiding Operations and cross-functional teams.
• Lead and coordinate other Manufacturing Specialists, and guide them on priorities and follow-up.
• Develop, review and improve manufacturing documentation, procedures, work instructions and technical standards.
• Maintain best practices for aseptic processing, contamination control strategy (CCS) and isolator technology, aligned with Annex 1.
• Lead investigations, deviations, change controls, CAPAs, risk assessments and other quality events.
• Review and approve batch documentation, and develop training on manufacturing and aseptic practices.
• Drive continuous improvement and take part in new products, technology transfers, equipment implementation and facility projects.
• Represent Manufacturing in cross-functional teams for equipment testing, commissioning, qualification and validation, and lead troubleshooting.
• Support regulatory inspections and audits, and promote safety, health and environmental compliance.

Required profile

• 6+ years of experience in GMP pharmaceutical manufacturing.
• Strong experience in aseptic manufacturing and advanced expertise in aseptic filling and isolator technology.
• Experience leading deviations, CAPAs, change controls and investigations.
• Knowledge of FDA, EU GMP and Annex 1 requirements.
• Fluent English.
• Desirable: experience supporting regulatory inspections and audits, CCS knowledge, qualification/validation and technology transfer experience, Lean Manufacturing or Six Sigma.