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R&D Engineer

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Viatris

13d ago

  • Job
    Full-time
    Junior Level
  • Science
    Engineering
  • Dublin
  • Quick Apply

AI generated summary

  • You need a Science/Engineering degree (Master’s preferred), 2+ years in pharma/device R&D, method validation experience, and strong statistical skills. Desirable: experience with injectors and regulatory writing.
  • You will conduct design verification, develop test methods, support combination product development, analyze data, ensure compliance, lead investigations, and maintain lab activities and EHS standards.

Requirements

  • Degree in Science/Engineering (Master’s preferred)
  • 2+ years experience in pharmaceutical and/or medical device development
  • Previous experience of working in R&D or Technical Services groups in the pharmaceutical or medical device industry
  • Previous experience in the development and validation of analytical methods
  • Experienced in application of statistical techniques for data analysis
  • Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks
  • Desirable
  • Previous experience working with pre-filled syringes, pen injectors or auto-injectors
  • Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485
  • Previous experience in technical writing to support regulatory communications, including submissions and information requests etc.
  • Demonstrable success in the alignment of Device/Combination Product development programs with, at a minimum, the US FDA requirements for Combination Product / Medical Device (preferably also other territories)

Responsibilities

  • Execute Design Verification activities within GDD programs in support of design control activities. Drive strategic development of Device and Product Performance (DPP) team process.
  • Provision of technical expertise to support the development of Combination Products.
  • Leading the Development and Validation of Test Methods to support Design Verification Testing either to internal/external test facilities or manufacturing sites.
  • Dealing with Viatris Affiliates and/or Third Partner Companies to support exhibit and registration batches, through review and implementation of controls and additional requirements if needed such as manufacturing investigations.
  • Trending and statistical analysis of analytical data including compilation of technical reports to support combination product development lifecycle.
  • Ensuring that the Combination Product meets any requirements for reliability, through implementation of appropriate controls and assessment of the product against suitable specifications.
  • Responsible for compilation and review of technical documentation within GDD in line with global regulatory requirements, guidance’s and the latest regulatory and industry thinking.
  • Lead and review device investigations and participate in GDD and technical investigation teams as required. Reporting and logging of aberrant results using Trackwise™.
  • Support of R&D Lab activities including, Equipment calibration and Qualification, Documentation requirements, Trackwise records.
  • Attending EHS training and maintaining responsibility for adhering to appropriate EHS procedures. Ensure the appropriate risk assessments are in place to perform required tasks.

FAQs

What is the main focus of the R&D Engineer role at Viatris?

The main focus of the R&D Engineer role at Viatris is to execute Design Verification activities, support the development of Combination Products, and drive the strategic development of Device and Product Performance processes.

What qualifications are required for this position?

A degree in Science or Engineering is required, with a Master's degree preferred. Additionally, 2+ years of experience in pharmaceutical and/or medical device development is necessary.

Is previous experience in R&D or Technical Services essential for this role?

Yes, previous experience working in R&D or Technical Services groups within the pharmaceutical or medical device industry is required for this role.

What specific technical skills are desirable for candidates applying for this position?

Desirable skills include experience with pre-filled syringes, pen injectors, or auto-injectors, knowledge of design control requirements per FDA 21 CFR part 820 and ISO 13485, and experience in regulatory communications and technical writing.

What type of analysis skills are important for this role?

Candidates should have experience in the application of statistical techniques for data analysis to effectively support the development lifecycle of combination products.

How does Viatris support employee development?

Viatris offers excellent career progression opportunities, along with competitive salaries and various benefits, to support employee development and work-life balance.

What is the significance of the Combination Product in this role?

The Combination Product is significant as it involves the integration of device technologies with pharmaceutical products, and the role focuses on ensuring these products meet reliability and regulatory requirements.

Are there opportunities to work on projects involving global collaboration?

Yes, the role involves dealing with Viatris Affiliates and third-party companies globally to support exhibit and registration batches, indicating a collaborative international environment.

What type of training is provided to employees in this role?

Employees are required to attend EHS (Environmental Health and Safety) training and adhere to appropriate EHS procedures, ensuring compliance with safety standards.

Does Viatris value diversity and inclusion in the workplace?

Yes, Viatris is dedicated to building a diverse, inclusive, and authentic workplace, emphasizing that diversity and inclusion are essential to their mission.

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Viatris

We believe in healthcare not as it is, but as it should be

Manufacturing & Electronics
Industry
10,001+
Employees
2020
Founded Year

Mission & Purpose

Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. Our differentiated portfolio includes brands, generics, and complex generics across multiple therapeutic areas. Our product diversity combined with our global scale, local approach and deep understanding of our markets allows for better access to customers and patients in more than 165 countries and territories. From our unique vantage point, we have the ability to touch all of life’s moments from acute conditions to chronic diseases. We put the person at the center of their own unique health journey. Viatris is more than a place to work, it is a place to make an impact in the world. Our culture is performance-driven, highly engaging and inclusive. We support and invest in our colleagues living, learning, growing and achieving on behalf of our mission. Four simple but powerful expectations define The Viatris Way – Own It. Be Real. Stay Agile. Take Pride. Ultimately, we know we are Stronger Together, working collaboratively and relentlessly across our company and with the broader global community, in pursuit of access. Because health matters everywhere.

Benefits

  • Retirement savings plans

  • Paid time off and holidays

  • Remote and flexible work arrangements in most locations