Technical Specialist (Vaccine Manufacturing, Remote/Europe)

Job summary

This role involves providing technical oversight in vaccine fill-finish operations at external manufacturing partners, ensuring compliance with industry standards and enhancing operational excellence.

Qualifications

• Degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related field, with experience in sterile manufacturing or vaccine fill-finish operations.
• Expertise in aseptic processing, cleanroom environments, and GMP compliance.
• Hands-on experience with vial filling, prefilled syringe systems, and automated assembly lines.
• Strong knowledge of deviation handling, root cause analysis, and process validation.
• Ability to interpret technical documentation and regulatory requirements.

Responsibilities

• Oversee vial filling and prefilled syringe operations at contract manufacturing organizations (CMOs), ensuring compliance with standards and best practices.
• Review and approve batch records, deviations, and change controls to maintain product quality.
• Assess CMO readiness, including equipment qualification and process capability.
• Drive troubleshooting and continuous improvement initiatives in fill-finish operations.
• Act as the primary technical interface with CMOs, supporting audits and inspections.

Skills

• Strong communication and stakeholder management skills.
• Structured and analytical mindset for navigating complex challenges.

Education

• Relevant degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related fields.

Tools

• Familiarity with GMP standards, aseptic processing equipment, and quality management systems.