Calypse

About the Company

Pour soutenir la recherche et améliorer chaque jour le quotidien des patients, depuis 2016, Calypse identifie et accompagne les meilleurs talents afin de répondre aux besoins des professionnels de l’industrie pharmaceutique en matière d’outsourcing et d’insourcing.

Parce qu’ils sont au cœur de notre offre de service, nos consultants, contractualisés en CDI, font l’objet d’une sélection exigeante par nos équipes RH. Dynamiques, impliqués et animés par la culture Calypse du résultat et de l’excellence, leurs champs d’expertise conjugués répondent à l’ensemble des besoins de l’industrie. Dans le cadre de la parfaite exécution des missions qui leurs sont confiées, ils disposent d’un manager Calypse référent, d’un suivi personnalisé et d’un programme de formation continue exigeant.

Réactivité, Qualité et Proximité sont les 3 piliers de notre offre de service 360° qui couvre l’ensemble des besoins de la chaîne de valeur : du Consulting à la CRO. Nous proposons ainsi à nos clients des compétences à forte valeur ajoutée dans les domaines de la pharmacovigilance, des affaires réglementaires, de la qualité, des études cliniques, de la biométrie et du market access.

Listed Jobs

Company Name

Calypse

Job Title

Spécialiste en microbiologie

Job Description

**Job Title:** Microbiology Specialist **Role Summary:** Serve as the technical reference and expert in microbiology for sterile and non‑sterile pharmaceutical product development. Provide microbiological design, qualification and start‑up expertise for injectable manufacturing, contribute to overall contamination control strategy, and ensure compliance with HSE and GMP standards. **Expectations:** - Advise on microbiological aspects of new chemical and biological product lines. - Lead risk‑based microbiology assessments and implement mitigation actions. - Drive surveillance of critical utilities (water, steam, gas) and maintain integrity of the microbiological program. - Manage internal and outsourced microbiology activities, including method development for sterility and endotoxin testing. - Handle OOS, OOT and other microbiological deviations, ensuring timely investigation and corrective action. - Maintain procedural compliance and support audit and inspection activities. **Key Responsibilities:** - Act as the technical microbiology reference for new product entities. - Contribute to design, qualification and commissioning of injectable production lines. - Develop and apply risk‑based microbiological analyses for facilities, processes and equipment. - Oversee the performance and qualification of critical utility microbiological surveillance. - Coordinate and supervise outsourced microbiology services and method development for R&D sterile and non‑sterile products. - Ensure application of HSE and GMP procedures, review and approve procedural documentation. - Investigate and resolve microbiological OOS/OOT incidents and other anomalies. - Participate in internal and external audits, inspections and regulatory reviews. **Required Skills:** - Deep expertise in sterile manufacturing and aseptic/isolation techniques. - Strong risk‑assessment and risk‑management methodology (e.g., FMEA, HACCP). - Experience with development and validation of sterility and endotoxin test methods. - Ability to manage subcontractors and negotiate technical deliverables. - Proficiency in handling deviations, root‑cause analysis and corrective‑preventive actions. - Knowledge of HSE, GMP, GMP for sterility, and regulatory requirements (FDA, EMA). - Excellent documentation, communication and audit‑interview skills. **Required Education & Certifications:** - Minimum 5 years of experience in sterile/ injectable environment within pharmaceutical or biotech industry. - Bachelor’s + 5 (equivalent to a Master’s degree) in Microbiology or a related life‑science discipline. - Demonstrated experience in aseptic production and/or use of isolators. - Familiarity with GMP, GMP for sterility, and relevant industry standards.

Orléans, France

On site

11-02-2026