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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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Purpose of the Role
Enable the efficient manufacture of pharmaceutical products, including highly potent compounds, while ensuring full compliance with cGMP and HSE requirements. The role is responsible for defining, implementing, improving, and supporting manufacturing processes and systems to deliver products safely, on time, within budget, and according to customer and business requirements.
Manufacturing Process Management
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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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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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Engages in the implementation of the Health, Safety and Environmental Management and Sustainability programs and procedures to safeguard employees and surrounding communities, developing requirements, supporting implementation through training and communication and monitoring implementation through audit and inspection. Conducts and supports incident investigations and risk assessments. Develops and maintains comprehensive knowledge and familiarity of regulatory and organization requirements and standards and works to ensure these requirements are fully implemented.
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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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Independent compliance function within HSE focused on the development and implementation of an internal audit methodology to monitor and report on management system capability and effectiveness. Develops and maintains comprehensive knowledge and familiarity of regulatory and organization requirements and standards and assesses and reports on how requirements are being met. Supports regulatory audits and new license applications.
- Design and guarantee the implementation of an effective HSE...
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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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As a key member of the Operations Planning team, you will play a critical role in ensuring the efficient planning and execution of manufacturing activities across the site. You will collaborate with cross-functional teams to balance customer demand, operational capacity, and business priorities while driving continuous improvement in planning processes and data integrity.
In this role, you will:
- Act as a champion for data excellence, ensuring planning and...
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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...