MES Validation Specialist – 12 Month Temporary Contract

Mylan Teoranta

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.

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 Role & What You Will Be Doing

The purpose of this role is to provide day-to-day support for Manufacturing Execution Systems (MES) and other GxP computerized systems at site, ensuring system reliability, effective issue resolution, and ongoing compliance through execution of validation activities.

The role will support system performance, troubleshooting, and continuous improvement initiatives, while contributing to validation and quality system activities as required.

Every day, we rise to the challenge to make a difference and here’s how the MES Validation Support role will make an impact:

• Provide first-line support for MES and other GxP systems, including issue investigation and resolution.
• Troubleshoot system issues and support root cause analysis to minimise impact on manufacturing operations.
• Support system enhancements, configuration changes, and continuous improvement initiatives.
• Execute validation activities (e.g. IQ/OQ/PQ) in line with site procedures and regulatory requirements.
• Assist in maintaining the validated state of GxP computerized systems.
• Support Change Controls, Deviations, CAPAs, and other QMS activities as required.
• Assist with preparation and review of validation documentation and system lifecycle documents.
• Support periodic reviews of systems to ensure ongoing compliance and performance.
• Collaborate with cross-functional teams including Manufacturing, Quality, and IT.
• Support audit readiness activities and provide documentation during inspections.
• Maintain system documentation and assist in managing the inventory of GxP computerized systems.
• Participate in user support and training activities for MES systems.
• Escalate issues appropriately and support resolution in a timely manner.

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:

• Minimum of a Bachelor's degree (or equivalent) in computer science, Information Technology, Engineering or a related field
• Strong problem-solving and troubleshooting skills
• Ability to work in a fast-paced manufacturing environment
• Good communication and teamwork skills
• Detail-oriented with a focus on compliance and documentation.
• Extensive hands-on experience with MES systems, preferably Rockwell PharmaSuite.
• Strong knowledge of Good Documentation Practices (GDP) and Good Testing Practices (GTP).

However, a combination of experience and/or education will be taken into consideration.  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. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

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. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

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. 

Viatris is an Equal Opportunity Employer.