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.
At Viatris, we are dedicated to building a truly diverse, inclusive, and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
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 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.