Sterile New Product Program Engineer

Viatris; Inverin; Presencial; EUR 70.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Excellent career progression

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Descripción de la vacante

Viatris is seeking a Sterile New Product Program Engineer to support a 3-year commercialization for a new cartridge-filling line. You will prepare facilities, utilities and equipment for aseptic processing and ensure IQ/OQ/PQ, validation, and regulatory alignment to enable successful process validation and launch.

You will collaborate with cross-functional teams, manage facility upgrades such as RABS/ORABS, qualification of utilities, and develop validation protocols to support a robust CQV

Formación

• Bachelor's degree in Engineering is required; PMP or equivalent a distinct advantage.
• Knowledge of Lean Six Sigma or equivalent continuous improvement methods.
• Experience in pharmaceutical/biopharmaceutical manufacturing, preferably sterile/aseptic.
• Hands-on experience with equipment qualification and validation; GMP knowledge essential.

Responsabilidades

• Support facility modifications and readiness for aseptic processing areas.
• Assist in implementing facility upgrades (RABS/ORABS) and qualification of utilities.
• Develop and review validation protocols; execute IQ/OQ/PQ and commissioning.
• Support validation of automated systems and process characterization for launch.

Conocimientos

Project management

Lean Six Sigma

GMP knowledge

Automation systems

Data integrity

Problem solving

Teamwork

Attention to detail

Educación

Bachelor's degree in Engineering

Descripción del empleo

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 executionandExhibit batches in manufacturing
• Collaborateonprocesscharacterizationandvalidationactivities

Documentation & compliance

• Supportdeviationandchangecontrolprocesses
• DevelopSOPfornewequipmentandprocesses

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About Your Skills & Experience

• 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 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.

Benefits at 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. Some of our benefits include the following on top of a competitive salary:

• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension

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 mea