Device Technology Deployment Manager
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Job Location:
Basel - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
PTT (MSAT & Engineering) is responsible for ensuring that PT stays at the forefront of technology in our facilities and supports our robust processes & efficient operations. We focus on integrating product health process health with equipment fit for purpose and facility readiness in support of the manufacturing network.
Global MSAT ensures seamless technical product health and lifecycle management develops and deploys new technologies and network standards systematically improves processes across the pharma portfolio solves operational challenges through data-driven insights and ensures sustainable scaling of innovations across the network.
Device Manufacturing Engineering defines and drives the Pharma TechOps device manufacturing process characterization development and technology deployment ensuring robust efficient compliant and cost-effective manufacturing of Roches medical devices and drug-device combination products across their entire life cycle from early design through continuous improvement.
The Opportunity
As the Device Technology Deployment Manager you lead and execute end-to-end device and packaging technology deployment projects and sub-projects within regulated manufacturing environments. Your role includes the following main responsibilities:
Drive strategic equipment and process initiatives to enhance product robustness efficiency and future-readiness including the introduction of novel technologies across the entire product lifecycle.
Own the technology lifecycle from concept assessment and pilot execution through to large-scale deployment rigorously evaluating feasibility scalability and implementation readiness
Proactively identify risks and implement effective mitigation strategies to ensure project objectives scope and timelines are achieved.
Oversee and execute critical equipment acceptance protocols (FAT SAT) coordinating user engagement and ensuring compliance with regulated standards.
Ensure timely review and approval of critical design qualification and validation deliverables (e.g. technical specifications test documentation) in partnership with Site Engineering Quality Device Development MSAT and User teams.
Ensure seamless cross-functional coordination and alignment among key project stakeholders including Automation Quality/Compliance Process Engineering and Manufacturing Operations.
Manage the full supplier relationship lifecycle including selection contract engagement performance monitoring and comprehensive review of critical technical documentation.
Who you are
We are seeking a highly experienced and technically proficient individual who is ready to lead complex technology deployment projects within a regulated environment.
Bachelors (B.S.) or Masters (M.S.) degree in Engineering (e.g. Mechanical Biomedical Chemical) Science or a closely related technical field.
7 years of technical Project Management experience (e.g. CAPEX-projects) specifically focused on the deployment industrialization and qualification of complex new equipment and technologies including expertise in supplier management URS machine risk assessments and C&Q strategies.
Experience in a highly regulated environment (preferably Medical Device or Pharmaceutical manufacturing) a solid understanding of cGMP ISO standards (e.g. ISO 13485) and FDA regulations (21 CFR Part 820) and deep knowledge of medical device manufacturing processes with hands-on experience in at least two of the following: Device Assembly Final Sterilization Processes or Final Packaging.
Proven ability to lead and support process development and technology scaling from early feasibility studies through to New Product Introduction (NPI) including familiarity with Automation/MES systems (a significant advantage).
Demonstrate exceptional communication negotiation and influencing skills be fluent in English and have a willingness to travel internationally (up to 25%) to support equipment acceptance testing (FAT) and site implementation. (PMP or other recognized certification is highly desirable.)
Ready for the next step We look forward to hearing from you. Apply now to discover this exciting opportunity!
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Manager
Key Skills
- Jenkins
- Python
- Active Directory
- VMware
- Engineering
- Tcp/IP
- Deskstops
- OS
- Windows
- Database
- Linux
- Java
- Troubleshoot
- Technical Support
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
