Sterile New Product Program Engineer

Viatris; Connacht; Presencial; EUR 70.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Pension

Bonus scheme

Excellent career progression

Descripción de la vacante

Viatris seeks a Sterile New Product Program Engineer to drive the 3-year commercialization program for a new aseptic cartridge-filling line. You will prepare facilities, utilities and equipment, ensuring design, qualification and validation meet GMP and regulatory standards for successful launch.

Responsibilities include facility readiness, RABS/ORABS upgrades, utilities monitoring, IQ/OQ/PQ commissioning, media fills, and QA collaboration.

Formación

• Bachelor's degree in Engineering (Mechanical, Chemical, Process or related)
• PMP or equivalent is a distinct advantage
• Knowledge of Lean Six Sigma or equivalent CI methodologies
• Experience in pharmaceutical/biopharmaceutical manufacturing, sterile/aseptic environments preferred
• Knowledge of GMP/regulatory standards (Annex 1, FDA)
• Hands-on equipment qualification and validation experience
• 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

Responsabilidades

• Support facility modifications and readiness activities for aseptic processing areas
• Assist in facility upgrades such as RABS/ORABS systems
• Support qualification and monitoring of critical utilities (WFI, clean steam, gases, HVAC)
• 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)
• Support PPQ batch execution and Exhibit batches in manufacturing
• Collaborate on process characterization and validation activities
• Develop SOPs for new equipment and processes
• Train operators on the new equipment and processes

Conocimientos

Problem solving

Communication

Teamwork

Multitasking

Quality focus

Lean Six Sigma

GMP knowledge

Data integrity

Educación

Bachelor's degree in Engineering

PMP or equivalent (advantage)

Herramientas

PLC/SCADA

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.

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 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 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.