Device Equipment Engineer

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

Our Global Device Development organization is an innovative, technically strong, and fully integrated team focused on delivering high-quality, safe, and effective device and combination products to meet evolving patient healthcare needs worldwide. It provides leadership, strategic oversight, direction, support, and hands-on training for medical devices and combination products.

The Device Equipment Engineer will act as the technical owner for assigned equipment workstreams, responsible for supporting specification development, supplier engagement, commissioning, qualification and transfer activities from concept through implementation. Working closely with suppliers, CMOs and cross-functional stakeholders, the successful candidate will execute equipment projects in support of GDD program delivery, ensuring solutions meet specification, quality and timeline requirements.

This global role provides exposure to the full product lifecycle, from development through commercialization, while offering an opportunity to develop advanced technical, project execution and leadership skills within the engineering organization.

Every day, we rise to the challenge to make a difference and here’s how the Device Equipment Engineer role will make an impact:

Key responsibilities for this role include:

• Provide Equipment ownership from specification development through delivery, commissioning, qualification and transfer to manufacturing, including equipment specification development and supplier interactions for device program activities.
• Support engineering projects through the development, specification, procurement, commissioning, qualification and transfer of manufacturing equipment and associated systems.
• Develop and implement engineering solutions that meet product and process requirements across device programs, including manufacturing processes, equipment specifications and automation solutions supporting product performance and quality requirements.
• Execute equipment and process development, characterization and testing activities, including process development, process characterization, scale-up and technology transfer activities.
• Execute and own equipment commissioning, qualification and verification activities, including URS, DQ, FMEA, IQ, OQ, PQ, FAT and SAT, from specification through implementation and transfer to manufacturing.
• Lead technical project execution activities associated with external suppliers, equipment manufacturers, Viatris affiliates and CMOs, including assembly, label and pack, supplier and CMO meetings, equipment reviews and project milestones.
• Participate in and support cross-functional project teams, working with manufacturing, quality, validation, supply chain and site engineering teams to execute engineering systems objectives in line with program delivery plans.
• Provide technical input and engineering documentation, including technical reviews, engineering reports, specifications, protocols, risk assessments, change controls and engineering assessments, together with accurate engineering reporting and project status updates.
• Support engineering risk assessments, troubleshooting and investigations, including equipment and manufacturing process issues, change control impact assessments, problem-solving activities, risk management and mitigation, process control alignment and mitigation activities.
• Support technology transfer, site integration and lifecycle activities, including coordination with site engineering teams, technical support to manufacturing sites and external partners, and continuous improvement of quality system processes associated with device development and lifecycle management.
• Support engineering operations and continuous improvement, including budget forecasting, invoice management, purchase order generation, Work Orders and CDAs, data analysis and performance monitoring, while developing technical and project management competencies through increasingly complex engineering projects and cross-functional collaboration.

The minimum qualifications for this role are:

• Degree in Engineering, Science or equivalent technical discipline.
• 3 - 5 years' experience in pharmaceutical, medical device, combination product, automation or related engineering environments.
• Demonstrated experience supporting engineering projects and equipment implementation activities.
• Strong technical documentation and report writing skills within a regulated environment.
• Strong communication skills and ability to work effectively within cross-functional teams.
• Enthusiastic, motivated and self-directed approach to problem solving.
• Attention to detail and systematic approach to execution of engineering activities.
• Desirable to have experience working with equipment suppliers, CMOs or contract engineering organizations.
• Familiarity with packaging development, transport trays and associated testing activities.
• Familiarity with AutoDesk, Microsoft Project, or similar engineering tools.
• Experience supporting medical device, combination product or pharmaceutical development projects.
• Familiarity with GAMP5 principles.

At Viatris, we offer competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to help make an impact on the lives of others.

At Viatris, we offercompetitivesalaries, benefitsandan inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.