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
As Sterile New Product Program Engineer , you will support the delivery of 3-year commercialization program for a new cartridge-filling product line. Reporting directly to the Strategic Development & Commercialization Lead, this role is responsible for executing engineering activities required to prepare facilities, utilities, and equipment for a new aseptic cartridge-filling process. You will ensure systems and processes are designed, installed, qualified, and validated in compliance with GMP and regulatory requirements, enabling successful process validation and commercial launch.
Every day, we rise to the challenge to make a difference and here’s how the Sterile New Product Program Engineer will make an impact:
Core facility & systems readiness
Support facility modifications and readiness activities for aseptic processing areas
Assist in implementing facility upgrades such as RABS/ORABS systems
Support qualification and monitoring of critical utilities (WFI, clean steam, gases, HVAC)
Commissioning, qualification & validation (the technical backbone)
Execute commissioning and qualification activities (IQ/OQ/PQ)
Support validation of aseptic systems including media fills
Develop and review URS, FAT/SAT, and validation protocols
Support validation of automated systems (PLC/SCADA)
Manufacturing readiness / launch support
Support PPQ batch execution and Exhibit batches in manufacturing
Collaborate on process characterization and validation activities
Documentation & compliance
Support deviation and change control processes
Develop SOPs for new equipment and processes
People/training (pick one, not both — redundant)
· Train operators on the new equipment and processes
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 Engineering (Mechanical, Chemical, Process, or related field) Project Management Professional (PMP) or equivalent a distinct advantage
Knowledge of Lean Six Sigma or equivalent continuous improvement and problem solving methodologies
Experience in pharmaceutical or biopharmaceutical manufacturing, with experience in sterile/aseptic environments preferred
Knowledge of GMP and regulatory standards (Annex 1, FDA)
Hands-on experience in equipment qualification and validation
Understanding of cleanroom operations and contamination control
Familiarity with CQV lifecycle and utilities systems
Working knowledge of automation systems and data integrity
Strong problem-solving and analytical skills
Ability to manage multiple tasks
Effective communication and teamwork
High attention to detail and compliance focus
At Viatris, we are…