Technical Lead Engineer (3 Year FTC)
1100 Mylan Pharmaceuticals Inc.
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Benefits offered by this job
Job summary
Viatris seeks a Technical Lead Engineer to provide engineering leadership for sterile fill-finish operations. You will own inspection readiness, oversee HVAC, clean utilities, and facility infrastructure, and lead qualification activities for new cartridge lines while supporting syringe and vial filling processes.
You will drive maintenance reliability and continuous improvement, coordinating with cross-functional teams to ensure compliant, safe, and efficient manufacturing.
Qualifications
- Bachelor's degree in Engineering required with >10 years pharma experience.
- Strong technical leadership and problem-solving skills.
- Experience with GMP, regulatory inspections and audit support.
Responsibilities
- Maintain regulatory inspection readiness for facilities and systems.
- Provide technical direction for cartridge filling line development and existing syringe/vial operations.
- Lead maintenance reliability programs and preventive maintenance strategies.
- Drive qualification lifecycle documentation and validation activities.
- Collaborate with Operations, QA, Validation, Maintenance, Facilities and external vendors.
Skills
Education
Tools
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.
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.
- 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.
- Provide technical leadership and oversight of critical facility systems including:
- HVAC and cleanroom environmental control systems
- Clean Steam systems
- Water for Injection (WFI)
- Purified Water systems
- Compressed gases
- Process chilled water
- Building Management Systems (BMS)
- 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.
- 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.
- 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.
- Lead & Support the development and execution of qualification lifecycle documentation including: partnering with MS&T department and Cartridge program manager
- User Requirement Specifications (URS)
- Functional Specifications (FS)
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Traceability matrices
- Engineering assessments
- 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.
- 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.
- 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.
- 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.
- 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.
- 10+ years' experience within pharmaceutical, biotechnology, or sterile manufacturing environments.
- Extensive experience supporting sterile fill finish operations.
- Strong experience with: HVAC systems in GMP environments, Clean utilities, Equipment maintenance programs, Reliability engineering, Qualification and validation activities, Regulatory inspections and audit support
- Experience supporting cartridge, syringe, or vial filling technologies is highly desirable.
- Sterile manufacturing processes
- GMP and regulatory compliance
- HVAC and cleanroom systems
- Clean utilities and critical facility infrastructure
- Asset lifecycle management
- Maintenance reliability methodologies
- Root Cause Analysis (RCA)
- Reliability Centered Maintenance (RCM)
- FMEA and risk management
- CMMS systems
- Change control management
- Qualification and validation lifecycle management
- Data analysis and performance trending
- Strong technical leadership & excellent problem-solving capability
- Proactive approach to compliance and reliability
- Ability to influence cross-functional teams with strong communication and stakeholder management skills
- Organized and detail-oriented with a Continuous improvement mindset
- Results-focused with high accountability
- Excellent career progression opportunities
- Work-life balance initiatives
- Bonus scheme
- Health insurance
- Pension
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
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. Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.
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