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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.
- Follow the daily priorities in order to accurately and promptly perform the allocated...
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- 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...
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- Lead the delivery of major engineering and capital projects from concept and feasibility through design, procurement, construction, commissioning and handover.
- Develop and execute project strategies, ensuring projects are delivered safely, compliantly, on time and within agreed budgets.
- Lead a team of project engineers and technical professionals, providing direction, coaching, development and performance management.
- Manage multiple complex...
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Suggests, develops and implements process analytical tools to boost the company efficiency in the areas of Drug Substance, Drug Product Intermediate and Drug Product. Oversees and qualifies the implementation of these tools in the manufacturing assets in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Assures modelling practices and methodologies are aligned with the state of the art. Promotes the scientific excellence and innovation in the area of Modelling and PAT and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
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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.
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Act as the company's Subject Matter Expert (SME) for:
- Process Validation
- Cleaning Validation
- Contamination Control Strategy
- New Product Introduction
- Regulatory segregation requirements for the manufacture and handling of highly active, potent, toxic, sensitizing, and other special-category compounds
- Aseptics
You will also be Responsible to:
- Promote the importance of high-quality work levels and the importance of a continuous improvement culture in all Quality and/or Regulatory Systems activities
- Open and maintain active and...
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This role serves as Hovione's global technical authority for microbiology and contamination control, ensuring that regulatory intelligence, scientific expertise, and industry best practices are translated into robust standards, harmonized procedures, and effective support for sites, development activities, and quality functions across the network. The position is focused on enterprise-wide technical leadership, process ownership, and strategic influence, with responsibility for shaping microbiological quality standards and contamination control practices, guiding risk-based decision-making, and driving consistency across Hovione's small molecule and biotechnology operations.Act as Hovione's Subject Matter Expert (SME) and Global...
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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.
- Evaluate...
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As Senior Finance Technician, you'll own the end-to-end Accounts Payable cycle for our sites in Portugal, Ireland, and the US, from invoice processing and vendor inquiries to reconciliations, expenses, and support month-end closing activities, from an AP perspective. We're looking for someone who wants to do more than process invoices: someone who will monitor, question, and improve how things work. You'll be part of our Finance team, collaborating...
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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...
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Enterprise leadership & strategy execution
- Set and execute the global compliance framework, including internal audit/self-inspection, inspection readiness, escalation pathways, and management review effectiveness.
- Serve as a corporate leader during health authority inspections and customer audits; ensure...
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We are looking for a Proposal Manager to lead the development of high-quality proposals for pharmaceutical outsourcing opportunities. Acting as the central coordinator of the proposal process, you will work cross-functionally to ensure submissions are competitive, compliant, client-focused, and aligned with business objectives.
This is an exciting opportunity for a professional with strong project management skills, commercial awareness, and a solid understanding of pharmaceutical development and manufacturing processes.
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- Participate in the definition of User Requirement Specifications (URS), ensuring solutions meet user needs while promoting safety, ergonomics, productivity, and intended use.
- Lead the design, development, and implementation of complex engineering projects, ensuring alignment with business objectives and engineering standards.
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To lead the reliability and engineering strategy for critical facilities, equipment and infrastructure within a highly regulated pharmaceutical environment. This is an opportunity for a reliability professional who wants to operate beyond individual equipment or maintenance programmes and have a site-wide impact on asset performance, reliability and lifecycle strategy.
Key Responsibilities include:
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- 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;
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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.
- Ensure the...
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Delivers win-win cost-effective solutions on time and in full through focused project teams speaking in one voice, working in an efficient and collaborative environment, thereby leading to long-term sustainability with satisfied stakeholders, including customers, suppliers, sponsors and team members. Lead the project teams, plan, set priorities, monitor and control, and take the decisions that result in delivery as per the agreed scope, budget and timeline. Maximizing financial performance and optimizing customer satisfaction are central to the function.
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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.
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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.
- To organize and define daily priorities within their assigned tasks in order to accurately...
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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.