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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;
- Participate in risk assessment of work permits and control of their appropriate execution;
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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.
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...
As an Associate Process Project Manager, you’ll work at the intersection of engineering and operations — supporting and leading smaller, process-focused projects that deliver measurable results. You will help plan, execute, and monitor projects that improve efficiency, introduce new equipment, and enhance manufacturing performance.
This role offers an excellent pathway for technically minded professionals who want to move into project management while maintaining a strong connection to...
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:
Assures the maintenance of process analytical tools (PAT) methods and performance in the manufacturing assets in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promotes the scientific excellence and innovation in the area of PAT and contributes with technical expertise to optimize PAT applications.
- Provide technical support (process analytical and statistical) in commercial projects;
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...
Performs procurement and sourcing functions which may include but are not limited to short and long-term category strategy development, supplier development and innovation enablement, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning/scheduling. Creates efficient integrated processes among internal functions and outside suppliers providing an efficient and transparent internal customer experience, compliant with quality assurance and sustainability requirements. Focuses resources on continuous improvement of the movement of materials through various processes and establishes key performance metrics and benchmarks to measure...
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.
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 unitary output (effective throughput per resource unit used). Responsible for developing, deploying and maintaining the most adequate methodologies and workflows, looking at maximization of workforce efficiency and adoption of the appropriate behaviours to enable engagement; as well as for deriving metrics...
Builds and maintains effective long-term relationships and a high level of satisfaction with key senior-level decision makers and influencers at an assigned group of customer accounts that may include major strategic customers within a geographic or industry focus. Identifies, develops and typically closes new sales opportunities. Creates demand for the organization’s products and services by raising their profile with customers. Achieves revenue targets by increasing revenue spend per account. Negotiates, with autonomy, highly complex and long term contracts. May conduct regular status and strategy meetings with the customer’s senior management to understand their needs and link...
- 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 and...
- 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;
- 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
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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 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.
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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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- Perform qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product.
- Recommend the analytical characterization package (Chemical, physical, performance) and control the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies.
- Promote the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property,...