Aseptic Process Expert – Sterile Fill/Finish

ten23 health; Lavamünd; Hybrid; EUR 80.000 - 110.000; Vollzeit

Benefits dieser Stelle

Flexible working arrangements

Open culture

Training opportunities

Competitive pension plan

Annual bonus

Zusammenfassung

ten23 health is seeking a Process Expert to lead aseptic manufacturing process optimization for sterile parenteral products. You will support transfer of new products, investigate deviations, and ensure robust GMP-compliant operations on the shop floor.

You will collaborate with Production and Quality Assurance, develop risk assessments, SOPs, and validation protocols, and provide technical leadership in audits. German and English fluency are essential.

Qualifikationen

• University degree in Pharmacy or related technical field.
• 5+ years of experience in sterile pharmaceutical manufacturing.
• Strong knowledge of aseptic manufacturing, fill-finish, and lyophilization.
• Experience with EU-GMP Annex 1, FDA 21 CFR 210/211, ISO cleanroom standards.
• Proven skills in root-cause analysis, CAPA, and data-driven decision making.
• Excellent German and English communication, able to guide cross-functional teams.

Aufgaben

• Provide process & compliance support, optimization, and continuous improvement of sterile manufacturing processes.
• Oversee transfer of new products and processes into manufacturing.
• Investigate deviations with structured root cause analyses and track CAPAs.
• Troubleshoot on the shop floor and coach production on GMP practices.
• Author and maintain risk assessments, SOPs, and manufacturing records.
• Support equipment, cleanroom, and system qualifications, and oversee validation protocols.
• Perform statistical evaluations of CPPs/CQAs to identify risks and inform PQR/APR.
• Act as technical representative during audits, ensuring audit-ready documentation.

Kenntnisse

Aseptic manufacturing

Fill-finish technology

Lyophilization

Process validation

Statistical data analysis

German and English communication

GMP compliance

Root-cause analysis

Ausbildung

University degree in Pharmacy

Related technical/natural science degree

Jobbeschreibung

ten23 health is seeking a Process Expert to lead aseptic manufacturing process optimization for sterile parenteral products. You will support transfer of new products, investigate deviations, and ensure robust GMP-compliant operations on the shop floor.

You will collaborate with Production and Quality Assurance, develop risk assessments, SOPs, and validation protocols, and provide technical leadership in audits. German and English fluency are essential.