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Enovalife

Enovalife

www.enovalife.com

4 Jobs

271 Employees

About the Company

Enovalife (formerly known as Business & Decision Life Sciences) is part of the Orange Business Group, an international consulting and Systems Integration company listed on the Eurolist C exchange.

Enovalife is specialized in the delivery of services and provision of solutions in the Life Sciences industry. With 25 years of experience, it supports its clients in the pharmaceutical, medical device, biotechnology, food and cosmetics industries.

Core skills include the provision of a range of expert CRO and consulting services (supporting clinical trials in the operational, data management, analytical, outcome research, and document writing area) and the implementation of technology-based, clinical applications and solutions tailored for the Life Sciences industry.

Enovalife is also a partner in the digital transformation of the pharmaceutical industry. Drawing on the expertise of the Orange Group, we carry out projects ranging from the collection of health data to the implementation of digital solutions for our customers.

Enovalife has offices in France and in Belgium and provides services all over Europe.

Listed Jobs

Company background Company brand
Company Name
Enovalife
Job Title
Data transformation lead F/H
Job Description
**Job title** Data Transformation Lead (F/H) **Role Summary** Lead CDISC SDTM programming for 5‑10 oncology and neuroscience clinical studies across all phases. Oversee programming subcontracted work, ensure quality and regulatory compliance, coordinate multi‑project delivery, and manage data transfers for clinical and data‑sharing purposes. **Expectations** - Minimum 5 years in clinical data management with CDISC expertise. - Deliver high‑quality SDTM datasets on schedule. - Initiate and supervise regulatory document creation (specifications, sDRG, DEFINE). - Coordinate multiple parallel studies while maintaining compliance and standardization. - Communicate effectively in English (written and spoken). **Key Responsibilities** - Provide oversight of CDISC SDTM programming across 5‑10 oncology and neuroscience studies. - Coordinate and review SDTM dataset programming performed by external vendors. - Conduct quality control of SDTM databases and participate in regulatory documentation preparation. - Program in SAS for SDTM dataset creation and validation. - Execute database transfers for clinical studies and data‑sharing with external partners. **Required Skills** - Strong CDISC SDTM programming experience and proficiency in SAS. - In-depth knowledge of regulatory requirements: GCP, ICH guidelines, Data Management best practices, CDISC standards. - Solid understanding of information systems and database structures. - Project coordination and multi‑project management capability. - Excellent communication skills in English (conversational and written). **Required Education & Certifications** - Bachelor’s degree in Life Sciences, Health Informatics, Computer Science, or related field. - Relevant certification in Clinical Data Management or CDISC (e.g., CDISC Certified, CDISC SDTM credential) is highly desirable.
Paris, France
Hybrid
Senior
18-12-2025
Company background Company brand
Company Name
Enovalife
Job Title
Chef de Projet Automaticien F/H
Job Description
**Job Title** Automation Project Manager (F/M) **Role Summary** Lead the audit, modernization, and strategic renewal of industrial automation systems within a pharmaceutical/biotechnology environment. Manage end‑to‑end projects, ensure compliance with GMP/BPF, and oversee qualification and supply chain for critical equipment. **Expectations** - Deliver comprehensive system audits, identify obsolescence, and define IT/OT architecture. - Create a strategic roadmap for replacement and procurement of critical components. - Execute qualification tests (SAT, IQ, OQ) and maintain regulatory compliance. - Manage project timelines, budgets, and supplier performance. - Provide technical support for system troubleshooting and access management. **Key Responsibilities** 1. **Audit & Strategy** - Conduct full inventory of existing automation assets and assess future obsolescence. - Verify documentation of functional, technical, and hardware specifications. - Update or create system architecture diagrams, covering racks, IT connections, and OT interfaces. - Inspect and confirm the compliance and operation of control programs, software, and consoles. - Develop a strategic roadmap prioritising replacements, and plan spare parts logistics. 2. **Project Management & Qualification** - Lead project planning, execution, and monitoring, coordinating with vendors and stakeholders. - Execute qualification stages (Installation Qualification, Operational Qualification, and Performance Qualification). - Resolve system issues, manage user access, and troubleshoot HMI and other interfaces. 3. **Technical Expertise** - Apply deep knowledge of Siemens TIA Portal (SCL, Structured List), WinCC; Schneider Unity, Control Expert. - Configure and troubleshoot industrial networks (Profibus, Profinet, Modbus, BACnet). - Manage Microsoft SQL Server 2012 and SQL Server Reporting Services 3.0 databases. - Administer Windows Server 2012 R2 and OPC server/client communications. **Required Skills** - Strong analytical and autonomous project management abilities. - Proficient in automation control engineering and industrial IT integration. - Familiarity with GMP, BPF, and V-cycle product development. - Experience with industrial networking and database administration. - Excellent communication, documentation, and stakeholder coordination skills. **Required Education & Certifications** - Bachelor’s or Master’s degree in Automation Engineering, Industrial Computing, or related technical field. - Professional certification or proven experience in GMP/BPF compliance is required. - Knowledge of regulatory qualifications (IQ/OQ/SAT) necessary.
Lyon, France
Hybrid
24-12-2025
Company background Company brand
Company Name
Enovalife
Job Title
Directeur / Directrice de Programmes d'Investissement Stratégiques F/H
Job Description
**Job Title** Director of Strategic Investment Programs (M/F) **Role Summary** Lead the execution of large‑scale, complex investment programs (€10–100 M) within the pharmaceutical/biopharmaceutical sector. Drive strategic and financial management, deliverables, risk mitigation, and stakeholder engagement while overseeing high‑performance matrix teams and ensuring regulatory compliance (cGMP, EHS, Quality). **Expectations** - Deliver programs on time, within budget, and to defined quality standards. - Provide evidence‑based decision support to senior leadership. - Champion continuous improvement and cultural transformation across cross‑functional teams. **Key Responsibilities** 1. **Strategic & Financial Leadership** - Define program scope, budgets, schedules, and risk frameworks. - Enable decision‑making for executive sponsors. - Monitor performance metrics; implement corrective actions for cost, schedule, and quality deviations. - Develop alternative concepts for complex, heterogeneous tasks and manage conflicting objectives. 2. **Team Management** - Build, structure, and motivate large matrix and functional engineering teams. - Promote agile project management practices and collaborative tools. 3. **Stakeholder Communication** - Design and maintain reporting architecture (charter, monthly reports). - Lead tailored communication and negotiation with external partners and internal stakeholders. 4. **Compliance & Quality Assurance** - Oversee EHS and Quality management throughout all project phases in partnership with specialized functions. **Required Skills** - Project/program management (BPF/PMI or equivalent). - Deep knowledge of cGMP, pharmaceutical/biopharma manufacturing processes. - Budgeting and financial stewardship for large capital projects. - Leadership of matrix and cross‑functional teams; conflict resolution. - Agile methodology implementation. - Strong written and verbal communication; advanced negotiation. - Cultural sensitivity and experience with international, multi‑cultural environments. **Required Education & Certifications** - Bachelor’s (or higher) in Engineering, Life Sciences, or related discipline. - Advanced education (MBA, MSc) preferred. - Certified Project Management Professional (PMP), Prince2, or equivalent is required. - Certification in GMP or relevant quality management systems preferred. ---
Lyon, France
Hybrid
24-12-2025
Company background Company brand
Company Name
Enovalife
Job Title
Ingénieur(e) Informatique Industrielle & Bases de Données F/H
Job Description
**Job Title:** Industrial IT & Database Engineer **Role Summary:** Provide specialized expertise in industrial IT and database management to support a multi-year MES migration project (Innova/paceX V3) while maintaining automation system stability. Act as a technical bridge between IT and automation teams. **Expectations:** Candidate must demonstrate autonomy, rigorous technical execution, and ability to prioritize across multiple projects. Core focus on system stability and cross-functional collaboration. **Key Responsibilities:** - Manage SQL database systems: script development, data migration, automation of tasks, and environment replication (DEV/TEST/PROD). - Proactively maintain production servers and develop deployment scripts (e.g., comparison tools) for secure system updates. - Coordinate data workflow between IT and automation systems, ensuring continuity of MES (Innova/paceX V3) and related platforms. - Create test documentation and support system qualification activities. - Facilitate automation team efficiency through technical tools and methodologies. - Deliver IT expertise to strategic industrial projects, including continuous improvement initiatives. **Required Skills:** - Proficiency in SQL database administration (management, migration, scripting). - Strong understanding of IT-automation system integration. - Experience with deployment script development. - Familiarity with test documentation and system qualification processes. - Exposure to industrial environments and multi-project management. - Preferred: SCADA systems (iFix, Historian) or pharmaceutical BPF/GMP knowledge. **Required Education & Certifications:** - Engineering degree or Master’s in Industrial IT/Computer Science. - No specific certifications required.
Lyon, France
Hybrid
24-12-2025