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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.
- Rigorously, efficiently and professionally, execute all production/HSE...
- Ensure the maintenance, service, repair and troubleshoot of all equipment and installations (mechanical) on site is performed as per Standard Operating Procedures, Maintenance Work Instructions or engineering best practices;
- Participate in risk assessment of work permits and control of their appropriate execution;
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- Provide support to automation system users. Troubleshoots and diagnoses equipment/system problems / failures. Prepares technical reports to document equipment modifications and equipment maintenance procedures;
- Contributes to the continuous improvement of systems to improve...
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.
- Rigorously, efficiently and professionally, execute all production/HSE...
As a CQV (Commissioning, Qualification, and Validation) Senior Engineer at Hovione, you lead complex engineering initiatives across pharmaceutical and chemical manufacturing environments. The role bridges technical excellence, regulatory compliance, and cross-functional collaboration to ensure robust, GMP-compliant systems and equipment.
Role Overview
You are specialized in the design, implementation, and qualification of manufacturing systems, utility infrastructures, and automation technologies. Your work ensures that...
We are seeking a highly experienced Senior Project Manager to lead and deliver strategic projects in a dynamic and transforming environment. The ideal candidate will have a strong background in Pharmaceuticals or FMCG, and be comfortable working with teams accustomed to structured, protocol-driven processes — while guiding them through change.
Role...
This role is responsible for managing the full contract lifecycle. It combines scientific knowledge with commercial insight to identify new opportunities, support client engagement, and drive business growth — all while ensuring compliance with internal and external standards.
Key Responsibilities:
Performs engineering work in operations, production, construction or maintenance environments. Responsibilities are within the Engineering Family as a generalist or in a combination of disciplines. Understands the roles and workflows of the Engineering and Maintenance functions.
- Manage and support the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies.
Delivers excellence in end-to-end process improvement practices, methodologies and behaviours to achieve transversally operational and support services areas’ efficiencies. Demonstrates particular leadership skills to influence the right behaviours and enable alignment of priorities across areas. Supports the continuous improvement cycle aiming at the sustainable increase of
Performs assembly, qualification and automation of facilities, equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes to the continuous improvement of systems to improve operations, providing them with the necessary automation technologies, capacity, reliability and in compliance with cGMP and project specifications.
- In the early designing phases, guarantee that cGMP and HSE requirements and adequate Engineering solutions...
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 quality...
Job Purpose
The Global Cyber Security Senior Manager is responsible for leading the development, implementation, and continuous improvement of Hovione’s cyber and information security strategy. This role ensures the protection of digital assets, compliance with regulatory requirements, and alignment with enterprise risk management objectives. This role is critical in safeguarding sensitive data,...
Performs qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product. Recommends the analytical characterization package (Chemical, physical, performance) and controls the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promotes the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Support and mentor production teams to optimize drug product manufacturing processes, minimize downtime, and maximize productivity;
- Identify and troubleshoot operational issues related to equipment and drug product processes, implementing innovative solutions to enhance efficiency and quality;
- Monitor and analyze production data to ensure compliance with regulatory standards and quality control measures;
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Defines and implements procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices.
Delivers excellence in end-to-end process improvement practices, methodologies and behaviours to achieve transversally operational and support services areas’ efficiencies. Demonstrates particular leadership skills to influence the right behaviours and enable alignment of priorities across areas. Supports the continuous improvement cycle aiming at the sustainable increase of
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
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Defines and implements procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices.
- Troubleshoot and resolve network-related issues affecting automation systems and ensure seamless IT/OT integration;
- Design, implement, and maintain automation network infrastructure, ensuring secure, scalable, and reliable communication;
- Implement and monitor cybersecurity measures to protect automation systems and ensure compliance with internal and external standards;
- Conduct Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to...
·Lead and manage cross-functional IT/OT projects in GMP-regulated pharmaceutical manufacturing environments.
·Oversee implementation and integration of systems such as SAP, MES, LIMS, ERP, SCADA, DCS, QMS, and data historians.