Sterility Assurance Expert

Work Schedule

Environmental Conditions

Job Description

Are you ready to join a dynamic team with diverse skills and make a significant impact? Join us as we strive for excellence in Sterility Assurance!

Reporting directly to the Sterility Assurance Manager, you will play a pivotal role in ensuring that the manufacturing processes for injectable drugs are conducted under the highest levels of Sterility Assurance in compliance with cGMP regulations.

As the Sterility Assurance Expert, you'll be responsible for defining and sustaining the “Contamination Control Strategy”, working in close collaboration with various site functions (EM, QAV, E&EV, Quality Operations, and Engineering) to ensure that systems and processes meet the highest aseptic standards.

Main responsibilities:

• Defines/supervises to the continuous improvement of the site Environmental Monitoring (EM) program, overseeing its long-term effectiveness.
• Oversees and supervises the Media Fill program.
• Supervises the application of Good Manufacturing Practices (GMP) related to aseptic behavior, facilitating their implementation through dedicated training.
• Oversees and supervises sterilization processes
• Collaborates with site functions in drafting and/or revising risk assessments aimed at identifying and evaluating potential gaps in production processes and utilities
• Leads and supports the evaluation of investigations impacting the sterility assurance status of manufacturing areas (e.g., adverse EM trends, media fill failures, sterility failures), actively participating in defining corrective/preventive actions.
• Supports the review and acts as a backup approver for Major/Critical Deviations and any Change Proposals impacting Sterility Assurance.
• Receives ongoing GMP training related to sterility assurance and transfers such training to site SMEs
• Act as the site SME for aseptic topics during regulatory and/or customer audits.
• Act as an SME in sterility assurance evaluations for new product introductions and new projects (e.g., new lines/processes).
• Actively participates in evaluating compliance with current regulatory requirements (Annex 1 and FDA guidelines) and future updates, assessing potential gaps and leading the implementation of identified best practices.

We are seeking a curious and driven candidate with strong interpersonal abilities to excel in a fast-paced environment. We are committed to equal opportunities and welcome applications from all qualified candidates.

Requirements:

• Degree in Biology, Microbiology or other scientific disciplines (Chemistry, CTF, Biotechnology).
• 2+ years of experience in a similar position within a regulated environment such as pharmaceuticals and/or biotech.
• Expertise in GMP regulations (EU and US).
• In-depth knowledge of sterile injectable drug production processes.
• Good English knowledge.

Knowledge, Skills, Abilities:

• Consolidated knowledge of production plants and manufacturing techniques in asepsis/terminal sterilization.
• Strong understanding of sterile product manufacturing and good aseptic practices.
• Principles of Quality Risk Management.

Join us and make a difference! Apply now to be part of a team that values innovation and quality.