Job Description Job Title: OT Engineer – Industrial Systems Integration / Tool Expert Company: Inova Location: Switzerland – Client site / Industrial environment Contract Type: Full-time – On-site Start Date: As soon as possible About Inova Inova is a Swiss consulting and engineering firm specializing in supporting life sciences and industrial clients through high-value expertise in quality, compliance, engineering, automation, and digital transformation. We help our clients deliver robust, compliant, and future-ready systems, from shopfloor execution to enterprise-level integration. Position Overview We are looking for an OT Engineer to support industrial projects as a tool expert, with a strong focus on the integration of machines and equipment into an existing IT/OT environment. In this role, you will act as the technical reference between project teams, suppliers, automation specialists, IT, OT, and quality stakeholders. You will ensure that new equipment is properly designed, connected, secured, and qualified within the industrial infrastructure. You will review and challenge supplier documentation, validate technical design choices, support the integration of machines into networks and automation environments, and ensure that qualification protocols are technically sound and aligned with project and compliance expectations. This position is ideal for a versatile OT profile with strong technical knowledge of industrial systems, networks, automation platforms, and cybersecurity principles. Key Responsibilities Act as the OT / tool expert in industrial equipment integration projects Support the integration of machines and production equipment into the existing IT/OT infrastructure Review, validate, and challenge supplier technical documentation, including MDS and design documentation Validate proposed technical designs with suppliers, internal engineering teams, automation teams, IT, OT, and quality stakeholders Assess machine connectivity requirements from an IT/OT perspective, including network architecture, interfaces, data flows, and system dependencies Review and challenge supplier qualification protocols, including FAT, SAT, IQ, OQ, and related technical test documentation Ensure that equipment integration is aligned with site standards, industrial network requirements, automation architecture, and cybersecurity expectations Support technical discussions with suppliers regarding automation, network configuration, interfaces, remote access, firewalls, switches, and system communication Contribute to risk assessments related to OT integration, cybersecurity, system availability, and operational continuity Coordinate with project teams to ensure that technical requirements are clearly defined, documented, and implemented Support troubleshooting activities during installation, commissioning, qualification, and start-up phases Ensure proper handover of technical documentation to operations, maintenance, automation, IT, and quality teams Promote robust, scalable, and secure OT practices across industrial projects Profile Requirements Degree in Automation, Industrial Engineering, IT, Computer Science, Electrical Engineering, or a related technical field Solid experience in OT, industrial automation, machine integration, or industrial IT environments Strong understanding of industrial systems, networks, switches, firewalls, communication protocols, and OT infrastructure Experience integrating machines or production equipment into industrial environments Ability to review and challenge supplier documentation, technical designs, and qualification protocols Good understanding of automation systems; experience with Siemens and/or DeltaV is a strong plus Knowledge of cybersecurity principles in industrial or OT environments is a major asset Experience in regulated environments such as pharmaceutical, biotech, medical device, or other GMP industries is an advantage Familiarity with qualification activities such as FAT, SAT, IQ, OQ, commissioning, and start-up support Versatile and hands-on profile, able to work across automation, IT, OT, engineering, quality, and supplier teams Strong analytical mindset with the ability to challenge technical solutions constructively Autonomous, proactive, and able to start quickly in a project environment Excellent communication skills and ability to interact with both technical and non-technical stakeholders Fluent French is mandatory English is a plus Why Join Inova? Take a key technical role in strategic industrial integration projects Work at the interface of automation, IT, OT, cybersecurity, and qualification Contribute to the successful deployment of critical equipment in industrial environments Collaborate with experienced project, engineering, automation, and quality teams Join a Swiss company that values precision, autonomy, collaboration, and technical excellence

Contexte Au sein du département Engineering & Sites and Facilities, vous pilotez l'exécution des travaux de construction sur site pour des projets CAPEX en environnement industriel réglementé (pharma, chimie, biotech ou similaire). Vous reportez directement aux Project Leaders et êtes le point de contact central pour l'ensemble des prestataires. Missions clés Définir la stratégie d'exécution : phasing, séquences de travaux, identification des chemins critiques Organiser le chantier : layout du site, installations temporaires, gestion des accès et zones de levage Coordonner les sous-traitants et les interfaces entre corps de métier (civil, mécanique, électrique, HVAC, tuyauterie) Valider les method statements et analyses de risques (JSA/JRA) avant démarrage des travaux Gérer les permis de travail au quotidien : ouverture, suivi, fermeture et archivage Réaliser des walkdowns/Gemba HSE réguliers pour identifier et corriger les situations dangereuses Suivre l'avancement physique, la productivité et les coûts chantier Produire un reporting quotidien clair à destination des Project Leaders et SME techniques Animer les réunions de chantier et coordonner les kick-offs avec les contractants Gérer les imprévus techniques et logistiques avec réactivité (replanning, changement de méthode) Maintenir une culture zéro accident : faire appliquer les règles HSE, mener les toolbox, suivre les KPI (TRIR, LTIR, near-miss) Compétences techniques requises Gestion de chantier en environnement industriel réglementé (pharma, chimie, biotech) Maîtrise des outils HSE terrain : permis de travail, JSA/JRA, EPI, Gemba/walkdowns Lecture de plans et documents d'ingénierie (DAO, P&ID, isométriques) Connaissance des corps de métier : génie civil, mécanique, HVAC, tuyauterie, électricité Suivi des indicateurs HSE (TRIR, LTIR, near-miss) et des KPI chantier Maîtrise de la Suite Microsoft Office (reporting, planning)

Job Description Job Title: Senior Process Expert – Fill & Finish / Isolator Technical Writing Company: Inova (www.inova-sa.ch) Location: Basel Area, Switzerland Contract Type: Full-time – On-site Start Date: ASAP About Inova: Inova is a Swiss consulting and engineering firm specializing in supporting life sciences industries through high-value expertise in quality, compliance, and digital transformation. We help our clients build robust, future-proof quality systems, from shopfloor execution to enterprise-level governance. Position Overview: We are seeking a Senior Process Expert – Fill & Finish to support a pharmaceutical client in the Basel area, with a strong focus on technical writing and operational documentation for aseptic manufacturing activities. This role is particularly focused on isolator-based operations and will involve the creation, review, and improvement of GMP documentation such as SOPs, Work Instructions, training materials, and process-related documentation for activities including compounding, smoke studies, media fills, PQ phases, and routine fill & finish operations. The ideal candidate combines deep hands-on process expertise with the flexibility and precision required to write clear, compliant, and operationally relevant documentation for manufacturing teams. Key Responsibilities: Write, review, and update GMP documentation related to fill & finish and aseptic processing activities Develop SOPs, Work Instructions, training materials, and operational guidance documents Support documentation for compounding, isolator operations, smoke studies, media fills, and PQ phases Translate hands-on process knowledge into clear, practical, and compliant procedures Work closely with Manufacturing, MSAT, QA, Engineering, and Validation teams Support preparation and execution documentation for process qualification and aseptic process simulations Ensure documentation is aligned with GMP expectations, internal standards, and operational best practices Contribute to training readiness by preparing clear and structured training content for operators and technical teams Provide senior process expertise while remaining hands-on and flexible in document execution activities Support start-up, remediation, or improvement activities related to isolator-based fill & finish operations Profile Requirements: Degree in Life Sciences, Pharmaceutical Sciences, Engineering, or a related technical discipline 10+ years of experience in pharmaceutical manufacturing, with strong expertise in fill & finish / aseptic processing Solid hands-on experience with isolator-based operations Strong knowledge of GMP requirements for sterile manufacturing environments Experience with compounding, smoke studies, media fills, PQ phases, and aseptic process documentation Proven ability to write high-quality SOPs, Work Instructions, training materials, and technical GMP documents Senior profile with the flexibility to perform detailed technical writing activities Strong collaboration skills and ability to interact with shopfloor, QA, Engineering, Validation, and Manufacturing teams Fluent in English; German is a plus Available to start ASAP in the Basel area Why Join Inova? Contribute to a key fill & finish project in a leading pharmaceutical environment Apply your senior aseptic processing expertise in a practical, hands-on documentation role Work closely with cross-functional teams on isolator-based operations Join a dynamic company that values technical excellence, precision, and collaboration How to Apply: Send your application to careers@inova-sa.ch Subject line: Senior Process Expert Fill & Finish – Basel Inova is an equal opportunity employer. We welcome diverse perspectives and are committed to fostering an inclusive workplace.

Position Summary The OPEX & Maintenance Methods Engineer is responsible for improving equipment reliability, manufacturing performance, and maintenance efficiency within a regulated medical device manufacturing environment. The role drives continuous improvement initiatives, optimizes maintenance strategies, and supports operational excellence across Production, Maintenance, Quality, and Engineering teams. Key Responsibilities Improve equipment performance, reliability, OEE, and production yield Lead troubleshooting and root cause analysis activities Define and optimize preventive maintenance strategies and maintenance plans, experience in digital calibration, for digital manufacturing Drive Lean Manufacturing initiatives (5S, Kaizen, continuous improvement) Develop and improve maintenance procedures and work instructions Support maintenance digitalization and performance monitoring tools Collaborate cross-functionally to reduce downtime and improve operational efficiency Support compliance with GMP, ISO 13485, IVDR, and FDA requirements Travail sur nomenclatures des pièces détachées Participate in investigation of deviations, audits, and equipment qualification activities Profile Experienced Technician or Engineering degree in Industrial, Mechanical, Automation, or related field 8+ years of experience in industrial manufacturing environments Strong background in maintenance methods, equipment reliability, and Lean Manufacturing Experience in Medical Device, Diagnostics, or Pharmaceutical industries preferred Strong analytical, troubleshooting, and problem-solving skills Fluent in French and English

Job Description Job Title: Qualification Specialist – Manufacturing Support Company: Inova (www.inova-sa.ch) Location: Lausanne Area, Switzerland Contract Type: Full-time – On-site About Inova: Inova is a Swiss consulting and engineering firm specializing in supporting life sciences industries through high-value expertise in quality, compliance, and digital transformation. We help our clients build robust, future-proof quality systems, from shopfloor execution to enterprise-level governance. Position Overview: We are looking for a Qualification Specialist with a strong generalist background to support manufacturing operations for a leading pharmaceutical client in the Basel area. This role focuses on equipment and utilities qualification across a wide range of systems, including laboratory and production environments (biotech, pharma, and chemical). A significant portion of the activities will involve periodic qualification of utilities, ensuring compliance, performance, and reliability over time. The position requires autonomy, organizational skills, and the ability to define and lead qualification strategies while collaborating with cross-functional teams in a GMP-regulated environment. Key Responsibilities: Execute qualification activities (IQ, OQ, PQ) for production and laboratory equipment Lead initial and re-qualification of equipment across biotech, pharma, and chemical environments Perform and manage periodic qualification of utilities (e.g., HVAC systems, gas networks) Contribute to and define qualification strategies aligned with site and regulatory requirements Support qualification of SIP cycles where applicable Ensure proper documentation in compliance with GMP standards Coordinate with Manufacturing, Engineering, QA, and other stakeholders Plan, organize, and manage qualification activities autonomously Support continuous improvement initiatives within qualification processes Ensure alignment with client culture, values, and operational excellence standards Profile Requirements: Engineering degree or equivalent scientific background Minimum 3 years of experience in qualification within GMP environments Strong hands-on experience with IQ, OQ, and PQ execution Proven experience in qualification of production and laboratory equipment Generalist mindset with the ability to handle diverse systems and environments Experience with SIP cycle qualification is a plus Experience in periodic qualification of utilities (HVAC, gas systems) strongly preferred Ability to define and lead qualification strategies Autonomous, well-organized, and proactive Fluent in French (mandatory) with good understanding of English Willingness to work on-site in the Lausanne area (100% position) Why Join Inova? Work on diverse qualification projects across multiple technologies and environments Play a key role in maintaining compliance and operational excellence in manufacturing Join a dynamic and collaborative team within a leading life sciences hub Contribute to high-impact projects in a GMP-regulated setting How to Apply: Send your application to careers@inova-sa.ch Subject line: Qualification Specialist – Basel Inova is an equal opportunity employer. We welcome diverse perspectives and are committed to fostering an inclusive workplace.