Senior Isolator & Aseptic Filling Specialist

Pci Pharma Services; León; On-site; EUR 80,000 - 110,000; Full time

Job summary

PCI Pharma Services in Leon, Spain, seeks a Senior Manufacturing Specialist - Isolator Technology to lead aseptic filling operations and isolator systems with deep GMP regulatory knowledge. You will drive risk assessments, CAPAs, and continuous improvements across Quality, Development, Validation, and Operations.

The role requires extensive experience in aseptic manufacturing and strong leadership to guide cross-functional teams, ensuring product quality and regulatory readiness.

Qualifications

• 6+ years of experience in GMP pharmaceutical manufacturing.
• Strong experience in aseptic manufacturing processes.
• Advanced expertise in aseptic filling operations and isolator technology.
• Experience leading deviations, CAPAs, change controls, and investigations.
• Knowledge of FDA, EU GMP, and Annex 1 requirements.
• Experience in manufacturing process improvement and troubleshooting.
• Ability to lead cross-functional initiatives and provide technical guidance to others.
• Fluent English.

Responsibilities

• Ensure compliance with all GMP requirements, manufacturing procedures, and applicable regulatory standards.
• Serve as the site SME for aseptic filling operations and isolator technology, providing technical leadership to Operations and cross-functional teams.
• Lead efforts to address manufacturing and regulatory compliance issues, ensuring timely resolution and implementation of sustainable corrective actions.
• Provide technical direction, prioritization, coordination, and follow-up of other Manufacturing Specialists to ensure effective execution of departmental objectives.
• Lead the development, review, and continuous improvement of manufacturing documentation, procedures, work instructions, and technical standards.
• Define and maintain best practices related to aseptic processing, filling operations, CCS, and isolator technology, ensuring Annex 1 compliance.
• Lead investigations, deviations, change controls, CAPAs, risk assessments, and other quality events.
• Review and approve manufacturing batch documentation for accuracy and compliance.
• Develop and deliver training on manufacturing processes and aseptic practices.

Skills

GMP manufacturing

Aseptic filling

Isolator technology

CAPAs & deviations

Regulatory knowledge (FDA/EU Annex 1)

Process improvement

Cross-functional leadership

English fluency

Job description

PCI Pharma Services in Leon, Spain, seeks a Senior Manufacturing Specialist - Isolator Technology to lead aseptic filling operations and isolator systems with deep GMP regulatory knowledge. You will drive risk assessments, CAPAs, and continuous improvements across Quality, Development, Validation, and Operations.

The role requires extensive experience in aseptic manufacturing and strong leadership to guide cross-functional teams, ensuring product quality and regulatory readiness.