Senior Process Engineer (Portfolio Strategy & New Product Introduction)

Viatris Inc. (NASDAQ: VTRS) 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.

With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris.

We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India.

Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X.

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.

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

Viatris is an Equal Opportunity Employer.

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; and
• Partnership – Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here's how the Senior Process Engineer (Portfolio Strategy & New Product Introduction) role will make an impact.

Role Purpose:

Reporting to the Process Manager/ Senior Process Manager (Portfolio Strategy & New Product Introduction), the primary role of the Senior Process Engineer (Portfolio Strategy & New Product Introduction) is to lead product manufacturing campaigns from the start of production and provide technical supervision with respect to quality and EHS until completion and release of the material.

For Senior Process Engineer, additional responsibilities include coaching junior engineers, managing complex manufacturing and operation issues, and leading teams in projects aimed at supporting manufacturing processes.

Key responsibilities for this role include, but are not limited to:

1) Portfolio Strategy & New Product Introduction (NPI)

• Support the site portfolio strategy by evaluating and implementing new product opportunities that align with the site's manufacturing capabilities, strategic objectives, and growth plans.
• Lead technical assessments and plant-fit evaluations for new products, including process, equipment, safety, quality, and capacity considerations.
• Partner with Technical Services / MS&T, Commercial, Supply Chain, Engineering, EHS, Quality and external stakeholders to support product selection, business case development, and introduction planning.
• Lead cross-functional new product introduction (NPI) activities, ensuring timely execution of technology transfer, scale-up, validation, and commercialization deliverables.
• Develop and execute process commercialization plans, including process design review, risk assessments, process validation strategies, and process performance monitoring.
• Identify process capability gaps and support the implementation of facility, equipment, digital, or procedural improvements required to enable future portfolio opportunities.
• Serve as the technical lead during technology transfer projects, ensuring effective knowledge transfer from sending sites, external partners, or development organizations.
• Support establishment of manufacturing cost models and identify opportunities to improve competitiveness through process optimization, yield improvement, cycle time reduction, and capacity enhancement.
• Monitor industry and internal Viatris portfolio developments and contribute technical insights to support long-term portfolio renewal and site growth strategies.
• Participate in cross-functional governance forums and project teams supporting portfolio expansion, network optimization, and strategic growth initiatives.

2) Process Development & Optimization

• Develop and maintain Master Manufacturing Instructions, which comprise of Manufacturing/Operating Instructions (MI/OI), and Records of Manual Operations (RMO),
• Develop and maintain process control system recipes,
• Develop and maintain process and production related Standard Operating Procedures (SOP),
• Monitor, identify, develop and implement improvements in processes and equipment.

3) Quality, Safety & Compliance

• Report, investigate and document findings of quality, EHS and compliance related issues observed during manufacturing or during batch record review,
• Report and investigate actions or behaviors that may negatively impact the desired outcome of the GMP process or activity,
• Develop, implement and monitor robust preventive measures for processing issues,
• Focus on Safety and GMP Compliance as operational priorities and as performance measures,
• Play a proactive role in ensuring the site safety and quality standards are adhered to

4) Operations Support

• Primary contact point and owner of assigned processes and equipment trains,
• Prepare pre-campaign manufacturing documentations and activities,
• Communicate on a regular basis to the plant personnel on process updates,
• Train the process technicians in the process and procedures as required,
• Ensure adherence to approved procedures and update the procedures as required, including the principles and practices of good data management (ALCOA).

5) Equipment Ownership & Audit Readiness

• Be the subject matter expert and go-to person for multiple equipment/GMP systems in production,
• Lead plant tour during audit,
• Present the system overview with evidence compliance to internal and external auditors,
• Be accountable for the Good Data Management and Data integrity understanding and performance.

6) Others

• Lead the commissioning activities of new equipment,
• Lead process performance qualifications and material qualifications,
• Lead complex process investigation,
• Lead complex continuous improvement initiatives/projects to enhance quality and safety compliance and process robustness,
• Coach, guide and develop the technical and compliance competencies of junior process engineers,
• Assume the manager's responsibilities during his absence.
• Other tasks as required by the job and manager.

Qualification

• Bachelors or Master's degree in engineering, preferably in Chemical Engineering or in sciences with a major in Chemistry.

Skills and Experience

This role requires strong technical expertise in chemical and manufacturing processes, including process development, validation, optimization, and process control systems. The candidate should have a solid understanding of GMP requirements, quality management principles, and data integrity practices to ensure regulatory compliance and consistent product quality. Experience in new product introduction (NPI), process design, and equipment commissioning is essential.

The ideal candidate will possess effective communication and interpersonal skills, with the ability to collaborate successfully within cross-functional teams. They should demonstrate leadership potential, a proactive mindset, and a passion for continuous improvement through innovation and problem-solving. A high degree of self-motivation, initiative, and the ability to work independently are also critical for success in this role.

Additional qualifications include:

• Preferably, minimum 5 years of experience in a relevant manufacturing environment.