Job Description
McDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines regardless of geography or circumstance; Leadership – Advancing sustainable operations and innovative solutions to improve patient health; Partnership – Leveraging our collective expertise to connect people to products and services. 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. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world. The Senior Device Equipment Engineer will be an SME in the management and delivery of equipment, inclusive of specification, procurement, delivery, qualification, and project management of the same. The successful candidate will lead equipment delivery projects with the suppliers, inclusive of budget management, and ownership for specification and qualification. The candidate will work in collaboration with cross organisational teams; R&D, CMO, Viatris entities, ensuring delivery to specification and local site requirements. This is a Global role that is key to the success of GDD’s varied product portfolio delivery and will provide the successful candidate exposure to all aspects of combination device design, development, and production. The Role & What You Will Be Doing Lead equipment delivery projects within GDD, and with CMO and suppliers. Build relationships with internal and external teams, developing the specifications pertaining to device assembly requirements. Management of suppliers to develop bespoke assembly solutions in line with specification. Project management of timelines and budget, inclusive of procurement of assets. Technical delivery of assets against specification, inclusive of lifecycle and QMS documentation. Point of contact for technical delivery with CMO and supplier. Relationship owner, and responsible for process delivery up to commissioning and qualification inclusive of optimization; PoC, PoP, etc. Every day, we rise to the challenge to make a difference and here’s how the Senior Device Equipment Engineer role will make an impact: Project owner from conception to realisation. Develop engineering systems strategy for program delivery. Pilot to scale up, subassembly, final assembly, transport, and auxiliary systems, establishing and maintaining timelines against organisation requirements and identify external partners to meet internal needs. Lead for engineering systems in cross departmental teams. Manage engineering system objectives in line with program delivery. Supporting the device program team through communication, plan management, technical review and execution, budgetary management, risk assessment, etc. Point of contact and relationship owner for external partners. Responsible for alignment of cross organisation requirement to GDD specification and needs. First point of contact for escalations, and alignment of external deliveries to internal plans. Accurately plan and manage budgetary needs to support program delivery, capital request development and approval, business justification and contract management. Supporting engineering systems with accurate reporting and supporting program management and finance metrics. Management of budgets associated with external suppliers, ensuring proactive budget forecasting, invoicing management at qualification phases and where appropriate cost reduction programs. Accountable for the design and development of device assembly solutions, from device concept to commercialisation, liaising with appropriate internal teams to establish process steps and appropriate controls, using good engineering practices. Identification and management risk through established practices, RAID for engineering systems and program delivery. Develop the specifications for complex automated processes, liaising with internal and external teams to identify and manage specification, drive Design for Assembly activities ensuring process performance metrics and product quality is attained. Author for but not limited to specifications, design review, PoP, PoC, engineering reports as required. Owner of all external activities at a supplier level, kick off, design review, process control development, FAT. And responsible for site integration; establish training needs, transport, site specification, commissioning and qualification activities, development batch record, process, and product (tray, temporary packaging, etc) transfer. Lead and facilitate effective program problem solving/discussion at a technical/project level to key stakeholders. About Your Skills & Experience For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences: Degree in Science/Engineering with 5+ years’ experience in pharmaceutical and/or medical device development or similar role. Strong project management experience is highly preferred. Enthusiastic, conscientious, highly driven and motivated person. Good communication skills and commitment to teamwork are essential. Writing technical reports and producing high quality documentation within a regulatory controlled GMP environment. Attention to detail in specifications and drawings with a systematic approach to tasks. Strong project management and/or project engineer experience, capable of establishing and maintaining timelines. Ability to work with suppliers and affiliate sites to set specifications and manage timelines. Ability to work flexibly and communicate complex information across multiple disciplinary teams, and sites, gain team member buy-in, and constructively resolve issues. Ability to work independently and proactively to establish own work processes. Ability to work on own initiative, prioritize work and manage several projects simultaneously. Experience in writing technical specifications and reports. Creativity, insight, and attention to detail to apply to the creation and development of reliable mass-produced devices. Ability to demonstrate and understand component – system interactions in attaining product quality, capable of leading technical challenges and establishing solutions. Willingness to travel as necessary. At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles. Benefits at Viatris 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. Some of our benefits include the following on top of a competitive salary: Excellent career progression opportunities Work-life balance initiatives Bonus scheme Health insurance Pension Diversity & Inclusion at Viatris At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. Sustainability at Viatris Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. Viatris is an Equal Opportunity Employer. #J-18808-Ljbffr