Validation Engineer

Posted 19 Jul 2022

Carrigtwohill, Cork - Ireland

Req Id 251502

Details

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 


Scope

Reporting to the Senior Validation Engineer – Filtration Site 2 (FS2) Blarney, the Validation Engineer is responsible for the design and execution of F2.0 validation project and strategies to support the implementation of Validation Master Plans and Qualification programmes.

The Validation Engineer works as part of a cross-functional team to deliver continuous improvements and exceed customers’ expectations, leading and supporting validation activities to ensure delivery of effective and well-documented qualification programmes.

The Validation Engineer will perform all activities in an efficient and competent manner with due regard to safety and quality, while ensuring a positive team environment and a focus on continuous improvement.

 

 

Responsibilities

  • Responsibility for the validation of manufacturing and all associated processes for the new manufacturing facility located in Blarney.
  • Execute and complete process, systems and equipment validations in accordance with Validation Master Plans, company policies and project schedules.
  • Prepare, execute and complete Validation Protocols and Reports, ensuring compliance to all relevant Quality standards and Regulatory requirements.
  • Participate in cross-functional teams to establish validation strategies and objectives to support process and equipment changes.
  • Ensure all departments understand and comply with requirements defined in validation programmes, provide training as necessary.
  • Maintain ongoing understanding and knowledge of requirements for validation in compliance with applicable regulations and guidance documents, provide updates to department management and cross-functional teams.
  • Participate in the review of validation practices and trends, identify opportunities for continuous improvement and complete improvement projects.
  • Monitor the progress of validation projects to ensure adherence to schedule and provide regular stakeholder updates.
  • Ensure thorough investigation of Quality and Validation issues using Root Cause Analysis methodology and implementation of robust corrective and preventative actions to prevent recurrence.
  • Lead and co-ordinate Risk Mitigation initiatives such as FMEA and Risk Assessments.
  • Adhere to all company EHS guidelines and Quality procedures.

 

Education

B.Sc. in an appropriate Science/Quality Assurance discipline or equivalent

 

General Skills

Thorough, practical and persistent self-starter with strong motivation

Good verbal and presentation skills

Strong written communication skills with proven technical and report writing skills

Demonstrated success working in a team environment

Effective time-management skills to meet project schedules

Good problem-solving skills

 

Travel

This role involves travel abroad.

 

 


 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

 

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html

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