Sterility Assurance Lead: Aseptic Excellence Leader

Galderma Pharma S.A; Uppsala kommun; Vor Ort; SEK 1.100.000 - 1.500.000; Vollzeit

Zusammenfassung

Galderma Pharma S.A. in Uppsala is seeking a Sterility Assurance Lead to own and drive the site’s sterility assurance strategy.

You will ensure compliance with global regulatory requirements and serve as SME for contamination control, aseptic processing, and sterilization validation. You will lead SAP/CCS programs, oversee environmental monitoring and media fills, drive CAPAs, and mentor colleagues while supporting audits and inspections.

Qualifikationen

• Bachelor’s or Master’s degree in Microbiology, Biotechnology, Pharmacy or related life sciences.
• 8–12 years in sterile manufacturing, microbiology or sterility assurance.
• Experience in GMP environments and regulatory inspections.
• Hands-on contamination control, environmental monitoring and aseptic manufacturing.

Aufgaben

• Lead the Sterility Assurance Program (SAP) and Contamination Control Strategy (CCS).
• Oversee environmental monitoring, cleanroom qualification and aseptic practices.
• Review sterilization validations and lead media fill programs.
• Drive contamination risk assessments, investigations and CAPAs.
• Act as SME during audits and inspections.
• Provide training and mentorship in sterility best practices.

Kenntnisse

Aseptic processing

Sterilization technologies

Environmental monitoring

GMP knowledge

Risk assessment

Data interpretation

Ausbildung

Microbiology degree

Biotechnology degree

Pharmacy degree

Jobbeschreibung

Galderma Pharma S.A. in Uppsala is seeking a Sterility Assurance Lead to own and drive the site’s sterility assurance strategy.

You will ensure compliance with global regulatory requirements and serve as SME for contamination control, aseptic processing, and sterilization validation. You will lead SAP/CCS programs, oversee environmental monitoring and media fills, drive CAPAs, and mentor colleagues while supporting audits and inspections.