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.
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.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!
