Senior Isolator & Aseptic Manufacturing Specialist

Between Group; Lugo; On-site; EUR 90,000 - 120,000; Full time

Job summary

PCI Pharma Services in León, Spain, is seeking a Senior Manufacturing Specialist - Isolator Technology. This permanent, Monday-to-Friday role focuses on aseptic filling and isolator technology within GMP-compliant manufacturing operations.

The candidate will lead technical operations, ensure regulatory adherence, and drive continuous improvement while mentoring operators and specialists in a fast-paced biopharma environment.

Qualifications

• 6+ years of GMP pharmaceutical manufacturing experience.
• Strong expertise in aseptic manufacturing and isolator technology.
• Experience leading deviations, CAPAs, change controls, and investigations.
• Knowledge of FDA, EU GMP, and Annex 1 requirements.
• Fluent English.

Responsibilities

• Ensure GMP compliance with all regulatory standards.
• Serve as SME for aseptic filling operations and isolator technology.
• Lead deviations, CAPAs, change controls, and investigations.
• Develop and maintain manufacturing documentation, procedures, and technical standards.
• Lead continuous improvement initiatives focused on process robustness and quality.

Skills

GMP manufacturing

Aseptic filling

Isolator technology

Regulatory compliance (FDA/EU GMP)

CAPA & investigations

Cross-functional leadership

Fluent English

Job description

PCI Pharma Services in León, Spain, is seeking a Senior Manufacturing Specialist - Isolator Technology. This permanent, Monday-to-Friday role focuses on aseptic filling and isolator technology within GMP-compliant manufacturing operations.

The candidate will lead technical operations, ensure regulatory adherence, and drive continuous improvement while mentoring operators and specialists in a fast-paced biopharma environment.