Sterile New-Product Launch Engineer

Viatris; Connacht; Presencial; EUR 70.000 - 100.000; Tempo integral

Benefícios oferecidos por esta vaga

Health insurance

Pension

Bonus scheme

Excellent career progression

Resumo da vaga

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.

Qualificações

• 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

Conhecimentos

Problem solving

Communication

Teamwork

Multitasking

Quality focus

Lean Six Sigma

GMP knowledge

Data integrity

Formação

Bachelor's degree in Engineering

PMP or equivalent (advantage)

Ferramentas

PLC/SCADA

Descrição da vaga

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.