Technical Lead Engineer (3 Year FTC)

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 Technical Lead Engineer is responsible for providing technical leadership, engineering support, and maintenance reliability oversight within a sterile injectable fill finish manufacturing facility. The role has primary responsibility for ensuring plant inspection readiness across engineering systems, with particular emphasis on HVAC, clean utilities, facility infrastructure, preventive maintenance programs, and associated Standard Operating Procedures (SOPs). The successful candidate will act as the engineering lead for the new product program proposed for the cartridge filling line while providing technical support for existing syringe and vial filling operations. The role is responsible for developing and maintaining qualification lifecycle documents, driving maintenance excellence initiatives, improving equipment reliability, and supporting process development activities to ensure compliant, safe, and efficient manufacturing operations. The Technical Lead will work closely with Operations, Quality Assurance, Validation, Maintenance, Facilities, and external contractors to ensure all systems remain in a sustained state of control and regulatory compliance. This role is a critical engineering leadership position responsible for ensuring the reliable, compliant, and efficient operation of sterile fill finish manufacturing systems while driving engineering excellence, maintenance reliability, and continuous inspection readiness. Key Responsibilities 1) Plant Inspection Readiness & Compliance Leadership 2) HVAC & Utilities Systems 3) Maintenance Excellence & Reliability Engineering 4) Cartridge Filling Line Technical Leadership Plant Inspection Readiness & Compliance Leadership • Lead engineering activities to maintain continuous regulatory inspection readiness. • Ensure HVAC systems, cleanroom infrastructure, utilities, and process equipment comply with GMP requirements and site procedures. • Drive remediation activities arising from audits, inspections, deviations, CAPAs and technical investigations. • Support regulatory inspections and customer audits as the technical subject matter expert for facilities and engineering systems. • Ensure engineering documentation is maintained in an audit-ready state at all times. • Periodically review engineering systems for compliance, risk, and operational effectiveness. HVAC & Utilities Systems • Provide technical leadership and oversight of critical facility systems including: o HVAC and cleanroom environmental control systems o Clean Steam systems o Water for Injection (WFI) o Purified Water systems o Compressed gases o Process chilled water o Building Management Systems (BMS) o Environmental monitoring support systems • Ensure robust preventative maintenance and reliability strategies are implemented for all GMP utilities. • Drive continuous improvement of utility performance through trend analysis and reliability programs. • Support qualification, requalification and periodic review activities for critical utility systems. Maintenance Excellence & Reliability Engineering • Champion maintenance reliability best practices across all production and utility assets. • Develop and optimize preventative maintenance (PM) programs using risk-based and reliability centered maintenance principles. • Lead root cause investigations and implementation of sustainable corrective actions for equipment failures. • Establish & report KPI’s • Drive predictive maintenance initiatives where appropriate. • Partner with maintenance teams to improve asset lifecycle management and spare parts strategies. • Promote a culture of reliability, ownership, and continuous improvement. Cartridge Filling Line Technical Leadership • Serve as Engineering Lead for the cartridge filling line new process development for next generation product. • Provide technical direction for specifying , troubleshooting, optimization, and lifecycle management of cartridge filling , dispensing and compounding equipment. • Lead equipment performance improvement projects. • Support process development, scale-up, and introduction of new products onto the cartridge manufacturing platform. • Coordinate equipment upgrades and implementation of technical improvements. • Ensure equipment operates within validated and qualified parameters. Validation & Qualification Support • Lead & Support the development and execution of qualification lifecycle documentation including: partnering with MS&T department and Cartridge program manager o User Requirement Specifications (URS) o Functional Specifications (FS) o Design Qualification (DQ) o Installation Qualification (IQ) o Operational Qualification (OQ) o Performance Qualification (PQ) o Traceability matrices o Engineering assessments o Periodic review documentation • Support commissioning and qualification of new equipment, facility upgrades, and utility systems. • Ensure documentation meets GMP, regulatory, and site requirements. • Support validation activities associated with process improvements and change controls. Syringe & Vial Filling Line Support • Provide technical engineering support to existing syringe filling operations. • Support reliability and maintenance activities on vial filling lines. • Collaborate with dedicated maintenance teams to maximize equipment performance and availability. • Lead technical investigations involving critical process equipment. • Support continuous improvement initiatives focused on productivity, quality, and operational excellence. Continuous Improvement & Process Development • Support process development initiatives to improve manufacturing efficiency and product quality. • Identify opportunities for equipment optimization and process simplification. • Lead engineering change control activities. • Apply Lean Manufacturing, Six Sigma, and Reliability Engineering principles where appropriate. • Participate in capital projects and technology transfer activities. Leadership Responsibilities • Provide technical mentoring and coaching to maintenance technicians and engineers. • Act as a key engineering SME across fill finish operations. • Foster a culture of safety, compliance, reliability, and continuous improvement. • Coordinate engineering activities across multiple functional groups and external vendors. 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: Education • Bachelor's Degree in Engineering (Mechanical, Electrical, Chemical, Manufacturing, Pharmaceutical Engineering, or related trades qualification with >10 years Pharma experience) • Advanced technical or reliability certifications are desirable. Experience • 10+ years' expe