Aseptic New Product Commercialization 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

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