Job description
Key Responsibilities
Quality & Sterility Assurance
* Own the MU’s sterility assurance risk profile, including the transversal strategy to mitigate/remediate risks and continuous improvement of the Sterility Assurance Quality System.
* Develop, implement, and maintain a comprehensive sterility assurance program/roadmap, including accountability for the MU’s Contamination Control Strategy.
* Monitor and improve manufacturing processes to identify potential sources of contamination and drive CAPA, e.g. via approval of PQ EM reports, facility design assessments, and EM/aseptic/bioburden/endotoxin risk assessments.
* Interpret microbiological data and trends, provide holistic recommendations, and drive implementation of process improvements; ensure timely and accurate reporting to relevant stakeholders and governance bodies (e.g. Quality Councils).
* Perform analyses related to the performance of the area of expertise (e.g. approval of periodic reports on viable/non-viable particles, flora analysis).
* Proactively monitor and oversee MU performance related to sterility assurance, including shopfloor Gemba walks, and influence MU/site management to achieve defined sterility assurance targets.
* Drive MU compliance to GMP and QMS requirements for sterility assurance (e.g. perform gap analyses and follow-up).
* Contribute to sterility assurance knowledge management and coordination across the site/network.
Regulatory / EHS
* Ensure compliance with local and international standards, cGMP, regulatory requirements, and internal QMS policies and procedures, as well as adherence to EHS rules.
* Act as front-room representative during regulatory and corporate inspections and internal audits for sterility assurance topics.
Financial & Projects
* No direct budget management, but minimize cost and resource impact of changes by aligning requirements with risk and added value.
* Participate in the design and review of CAPEX projects impacting sterility assurance to assess and secure their impact on the MU.
Change & Continuous Improvement
* Manage Change Controls related to sterility assurance initiatives in the MU and contribute to the overall improvement of vaccines/sterile manufacturing and supply.
* Share and integrate best practices within the site and the wider company network.
Knowledge, Training & Coaching
* Maintain up-to-date expertise in sterility assurance, microbiology, aseptic manufacturing, and quality management (e.g. through training package creation and continuous learning).
* Identify MU needs and provide coaching/training in the area of expertise (e.g. aseptic technique refreshers, contamination control training).
* Ensure proactive benchmarking across MUs, site SMEs, and local/global departments.
Candidate Profile
Education
* Minimum: Bachelor’s degree in Sciences or equivalent experience.
o Preferred specializations: Microbiology (strong plus), Agronomy, Pharmacy, Biology, Biochemical Engineering.
* Preferred: Master’s degree in Sciences or equivalent experience (same specializations).
Reason: The role operates in a highly complex aseptic manufacturing environment requiring in-depth knowledge of aseptic processes, environmental monitoring, and microbiological testing.
Experience
* At least 5 years of professional experience in a pharmaceutical manufacturing environment producing sterile drugs or vaccines.
* Strong understanding of regulatory requirements, including cGMP and relevant international guidelines.
* Lean / Six Sigma knowledge is an advantage (e.g. Green Belt certification).
Skills & Competencies
* Strong sterility assurance and microbiology background, with very good knowledge of cGMP for biological products.
* Ability to balance GMP requirements with manufacturing reality, making pragmatic, risk-based decisions.
* Strong analytical, problem-solving, and root cause analysis skills; flexible and critical thinking.
* Continuous improvement mindset with the ability to challenge the status quo constructively.
* Excellent interpersonal and communication skills; engaging and decisive leadership style.
* Proven influencing skills at all levels of the organization (shopfloor to senior management).
* Training and mentoring capabilities to upskill teams in aseptic behavior and sterility assurance.
* Strong quality and results-oriented mindset.
* Languages: Very good level of French and English, spoken and written.
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.