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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...
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.
The Senior Project Scheduler will effectively plan, track, and optimize project schedules, their plays a crucial role in project management by ensuring that projects are planned, tracked, and executed efficiently.
Responsibilities:
- Develop and maintain detailed project schedules using tools like...
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, intellectual property, and ensuring business continuity in a...
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 of their products, materials, components and/or operations.
- Develop and execute commissioning, qualification, and validation protocols (DQ, IQ, OQ) for automation and control systems;
- Ensure compliance with GMP, GAMP 5, and 21 CFR Part 11 during all phases of system implementation and operation;
- Author and maintain validation documentation, including protocols, reports, and traceability matrices for computerized systems;
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·Lead and manage cross-functional IT/OT projects in GMP-regulated pharmaceutical manufacturing environments.
·Oversee implementation and integration of systems such as SAP, MES,...
- Develop, configure, and implement software for PLC, DCS, and SCADA systems across various automation platforms;
- Translate functional design specifications into reliable and maintainable automation code;
- Troubleshoot and resolve software issues during project execution and post-implementation support phases;
In this role, you will build and maintain strong, long-term relationships with senior decision-makers and key influencers within a designated portfolio of customer accounts, which may include major strategic clients in specific geographic or industry sectors. You will ensure a high level of customer satisfaction by staying closely aligned with their needs and expectations. You will identify and develop new sales opportunities and are typically responsible for successfully closing them. By increasing the visibility and perceived value of the company’s products and services, you will generate demand and strengthen our market...
Responsibility over the development, scale-up, registration/validation of drug substance, particle engineering and drug development programs in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Oversees the manufacturing process for clinical or commercial supplies of materials in cooperation with areas and supports safety/hazard analysis and other technical support areas as required. Promotes the scientific excellence and innovation in the area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
The Sourcing Specialist Trainee will learn to make informed procurement decisions during the RFP2Bid and Cost Assessment Processes. This includes actively participating in Screening Meetings to assess potential supply constraints, mitigate risks, and ensure strategic and timeline alignment from the onset of new opportunities. The Trainee will also leverage technical knowledge in chemistry and chemical processes to optimize supplier selection, ensure compliance with industry regulations, and drive alignment between technical requirements and procurement strategies.
The REGENERAR project, spanning three years and commencing on March 1, 2024, aims to develop a non-viral delivery formulation up to TRL4 for gene editing applications. This formulation is intended to promote regeneration in tissues with limited self-repair capabilities.
The consortium comprises six partners from three EU Member States:
- Two academic institutions: University of Coimbra (Portugal) and...
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Develop detailed civil engineering designs and plans for pharmaceutical facilities;
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Conduct site assessments and feasibility studies for new construction projects;
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Collaborate with architects, mechanical engineers, and other stakeholders to ensure integrated project delivery;
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- Develop scalable, secure, and efficient digital architectures that align with organizational goals and industry best practices;
- Collaborate with IT teams to integrate various platforms, systems, and applications ensuring seamless interoperability;
- Work closely with cross-functional teams (development, operations, security, and business units) to ensure digital architecture supports business objectives;
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- Assist in supplier quality related activities in support of business goals
- Follow-up with suppliers to obtain required documentation for approval and maintenance of supplier qualification processes
- Ensure that Hovione receives from the supplier the appropriate documentation to perform the supplier qualification
- Follow-up with internal teams to obtain inputs for approval and maintenance of supplier qualification processes
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Performs procurement and sourcing functions which may include, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning. Focuses resources on continuous improvement of the movement of materials through various processes and establishes key performance metrics and benchmarks to measure actual performance against goals regularly.
- Develop and execute cost-saving strategies for indirect materials and services.
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Hovione is a global CDMO dedicated to helping pharmaceutical clients bring innovative therapies to market. We are now hiring a Senior Quality Manager to join our Lisbon-based team. This role is a strategic leadership position with oversight of quality systems, compliance, and regulatory readiness for our manufacturing operations, with a focus on API, raw materials, and drug product environments.
We are seeking an experienced professional from the