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Provides administrative support to employees or groups in the organization. Maintains files, records, calendars and diaries. May arrange business travel, coordinate meeting arrangements and / or track expenses. Uses standard and/or advanced business software applications (e.g Microsoft Office, SAP, documentation control, analytical software) to prepare correspondence, presentations, agenda, minutes, etc. Acts as key user for area specific tools. Prepares technical reports, document or indicators based on specialized documents. Updates planning and communications in support of decisions made.   -

- Lead Commissioning, Qualification and Validation (CQV) activities for facilities, equipment, utilities, and systems in compliance with GMP and regulatory requirements. - Develop and execute CQV strategies, including DQ, IQ, OQ, and PQ, ensuring validation readiness and successful project...

Ensure full compliance with cGMP, GDP, and regulatory requirements across product lifecycle activities, acting as the ultimate authority for batch certification and release. Drive a strong quality culture, safeguard patient safety, and enable business continuity through effective quality oversight and decision-making. Quality & Compliance Leadership •    Ensure compliance with GMP,...

- Identify and survey critical instrumentation assets (flow meters, thermometers, pressure and temperature transmitters, etc.) across the plant for which spare parts are currently unavailable. - Codify identified instruments within the plant's asset management framework, ensuring full...

Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global...

- Fulfill all applicable current Good Manufacturing Practices (cGMP) and Health Safety and Environment (HSE) regulations and relevant legislation by adhering to Hovione´s policies and procedures (COPs, HBR, SOPs and others) and industry standards while conducting all activities; - Plan and design manufacturing processes that ensure the production of intermediates and final products according to the project plan (reliably, right first time, on...

Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.   - Fulfill and rigorously promote all applicable Good Manufacturing Practices (GMP)...

Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.   - Fulfill all applicable current Good Manufacturing Practices (cGMP) and Health...

- Conduct Impact Assessments and Risk Assessments for new or modified systems; - Draft User Requirements Specifications (URS) to support project and compliance needs; - Contribute to Enhanced Design Reviews, ensuring alignment with technical and regulatory standards; -

Automation & OT Engineer The Automation & OT Engineer is responsible for the design, implementation, qualification, and lifecycle management of industrial automation hardware and operational technology systems. This role ensures robust, safe, and compliant operation of process equipment through high‑quality hardware engineering, reliable control systems, and secure OT–IT network integration. Key Responsibilities

Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the...

- Develop and implement asset management strategies for critical equipment, including PMP, critical spare part identification, and optimization of spare part inventories. Ensure up-to-date and accurate equipment BOM. - Lead troubleshooting efforts for equipment malfunctions; perform Root Cause Analysis (RCA) and implement effective Corrective and Preventive Actions (CAPA) to minimize downtime. - Integrate maintenance activities into the Computerized Maintenance Management System (CMMS), preferably SAP PM, ensuring...

Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.   - Fulfill and rigorously promote all applicable Good Manufacturing Practices (GMP) and Health Safety and...