Process Engineer

Viatris; Inverin; On-site; EUR 65,000 - 90,000; Full time

Job summary

Viatris is seeking a Process Engineer to lead local medical and manufacturing teams, aligning with regional medical strategies and driving improvements across operations. You will collaborate with cross-functional teams, regulatory, and external partners to ensure safe, compliant, and efficient production of medicines.

The role focuses on process optimization, equipment qualification, new product introductions, and CAPA-driven improvements, with strong emphasis on GMP, EHS, and quality systems

Qualifications

• Bachelor’s Degree in Chemical Engineering or related discipline.
• Experience in pharmaceutical/regulated manufacturing.
• Experience supporting GMP manufacturing operations.
• Knowledge of equipment qualification and process validation.
• Experience with Lean/Six Sigma/Operational Excellence methodologies.

Responsibilities

• Provide day-to-day technical support to manufacturing operations to meet targets safely and efficiently.
• Analyse processes, equipment, and systems to identify optimization opportunities.
• Lead capital and continuous improvement projects from concept through design, procurement, installation, commissioning, qualification, validation, and handover to operations.
• Collaborate with engineering contractors and vendors to deliver projects safely and on schedule within budget.
• Support New Product Introduction (NPI), technology transfer, and scale-up activities.
• Develop and maintain process parameters and controls to ensure product quality and regulatory compliance.
• Specify, select, design, procure, install, upgrade, modify, commission, qualify, and validate manufacturing equipment and systems.
• Lead and support equipment, process, cleaning, and utility qualification and validation activities.
• Ensure all activities comply with GMP, EHS, Quality, and regulatory requirements.
• Perform root cause investigations and implement CAPA for issues.
• Prepare technical documentation including SOPs, specifications, validation protocols and reports, risk assessments, and change controls.
• Collaborate with Operations, Quality, Validation, Maintenance, and Supply Chain for project delivery.
• Deliver technical training and coaching to manufacturing and engineering personnel.
• Drive Lean, Six Sigma, and Operational Excellence in daily operations.
• Monitor process performance through data analysis and trending to improve OEE and quality.
• Support regulatory inspections and audits with inspection-ready documentation.

Skills

GMP manufacturing

Process engineering

Project management

Root cause analysis

Data analysis

Lean Six Sigma

Education

Bachelor’s Degree in Chemical Engineering

Tools

CQV

Validation protocols

Job description

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

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

This position will lead the local medical team, ensure alignment and execution of local/regional medical strategy, collaborate with cross-functional teams and influence key healthcare stakeholders to drive meaningful impact for patients and the business.

• Provide day-to-day technical support to manufacturing operations to ensure production targets, quality standards, and business objectives are achieved safely and efficiently
• Analyse existing manufacturing processes, equipment, and systems, identifying opportunities for optimisation, capacity enhancement, reliability improvement, cost reduction, and compliance improvements.
• Lead and support capital and continuous improvement projects from concept through design, procurement, installation, commissioning, qualification, validation, and handover to operations.
• Work with engineering contractors, equipment vendors, and service providers to ensure projects are delivered safely, on schedule, within budget, and in compliance with site requirements.
• Support New Product Introduction (NPI), technology transfer, process scale-up, and commercialization activities, ensuring successful integration into routine manufacturing operations.
• Develop, optimise, and maintain process parameters and manufacturing controls to ensure product quality, process robustness, reproducibility, and regulatory compliance.
• Specify, select, design, procure, install, upgrade, modify, commission, qualify, and validate manufacturing equipment, utilities, and process systems.
• Lead and support equipment, process, cleaning, and utility qualification and validation activities, including protocol generation, execution, deviation management, and final reporting.
• Ensure all engineering and manufacturing activities comply with GMP, Environmental Health & Safety (EHS), Quality, and regulatory requirements.
• Perform root cause investigations and implement effective corrective and preventive actions (CAPA) to address process, equipment, and operational issues.
• Prepare and maintain technical documentation, including Standard Operating Procedures (SOPs), engineering specifications, validation protocols and reports, risk assessments, change controls, commissioning documentation, and technical evaluations.
• Collaborate with Operations, Quality, Validation, Maintenance, Supply Chain, and external partners to support site objectives and project delivery.
• Deliver technical training and coaching to manufacturing and engineering personnel to support operational excellence and knowledge transfer.
• Drive a culture of continuous improvement through the application of Lean, Six Sigma, problem-solving, and operational excellence methodologies.
• Monitor process performance through data analysis and trending, identifying opportunities to improve quality, efficiency, reliability, and overall equipment effectiveness (OEE).
• Support regulatory inspections, customer audits, and internal audits, ensuring engineering systems and documentation are inspection-ready at all times.

Perform other duties as assigned.

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:

• Bachelor’s Degree in Chemical Engineering, Mechanical Engineering, Process Engineering, Pharmaceutical Engineering, Biotechnology, Industrial Engineering, or a related scientific/engineering discipline.
• Proven experience in a pharmaceutical, biopharmaceutical, medical device, or regulated manufacturing environment.
• Demonstrated experience supporting GMP manufacturing operations.
• Strong understanding of process engineering principles, equipment design, and manufacturing systems.
• Experience managing engineering projects from concept through implementation.
• Knowledge of equipment qualification and process validation requirements.
• Experience authoring and reviewing technical documentation, including SOPs, protocols, reports, change controls, and risk assessments.
• Strong problem-solving, root cause analysis, and troubleshooting skills.
• Excellent communication and stakeholder management skills, with the ability to work effectively across multidisciplinary teams.
• Proficiency in data analysis and the use of engineering tools to identify process improvement opportunities.
• Familiar with Steam utilization, Autoclaves, WFI still, Clean steam, HVAC systems, Compressed air, Filling lines, Packaging lines, PLC
• Direct involvement in New Product Introduction (NPI), technology transfer, and process scale-up projects.
• Experience with commissioning, qualification, and validation (CQV) activities.
• Knowledge of cleanroom operations, HVAC systems, purified water systems, clean steam, and other GMP utilities.
• Experience applying Lean Manufacturing, Six Sigma, Operational Excellence, or Continuous Improvement methodologies.

Why 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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.

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 offercompetitive salaries, benefitsand 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.