Job Details
Project Manager - Sterialisation
5515
Posted: 20/03/2025
- €Competitive
- Bucharest, Romania
- Contract
Project Manager – Sterility Assurance
Location: Bucharest, Romania (Hybrid, 20% Remote)
Contract: Freelance
Duration: 6 Months (Possible Extension)
Role Overview:
We are looking for a Project Manager with expertise in Sterility Assurance to lead projects in a GMP-regulated environment. The ideal candidate has 6+ years of experience in project management and sterility assurance within pharmaceuticals, biotech, or medical devices.
Key Responsibilities:
Location: Bucharest, Romania (Hybrid, 20% Remote)
Contract: Freelance
Duration: 6 Months (Possible Extension)
Role Overview:
We are looking for a Project Manager with expertise in Sterility Assurance to lead projects in a GMP-regulated environment. The ideal candidate has 6+ years of experience in project management and sterility assurance within pharmaceuticals, biotech, or medical devices.
Key Responsibilities:
- Oversee aseptic processing, contamination control, and sterility assurance activities.
- Ensure compliance with EU GMP Annex 1, FDA, EMA, and ISO 13408.
- Manage cleanroom validation, environmental monitoring (EM), and risk assessments (QRM, FMEA).
- Support media fills, sterilization validation (steam, dry heat, gas, filtration), and CAPA implementation.
- Prepare regulatory documentation and support audits.
- 6+ years of project management experience in sterility assurance.
- Strong knowledge of GMP, cleanrooms (Grade A-D), sterility testing (USP <71>, ISO 14644), and microbiological controls.
- Experience in process simulations, contamination risk management, and aseptic process validation.
Guy Shipman
Practice Lead | Regulatory Affairs
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