Aseptic Cartridge Fill Program Engineer

Viatris; Galway; On-site; EUR 70,000 - 110,000; Full time

Benefits offered by this job

Health insurance

Pension

Bonus scheme

Career progression

Diversity & Inclusion

Job summary

Viatris in Galway is seeking a Sterile New Product Program Engineer to support a 3-year commercialization program for a new aseptic cartridge-filling line. You will prepare facilities, utilities and equipment for GMP-compliant processes and ensure design, installation, qualification and validation activities align with regulatory requirements for a successful launch.

Reporting to the Strategic Development & Commercialization Lead, you will execute IQ/OQ/PQ, support validation of WFI, clean steam

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Chemical, Process, or related).
• Experience in pharmaceutical/biopharma manufacturing and sterile/aseptic environments preferred.
• Knowledge of GMP and regulatory standards (Annex 1, FDA).
• Hands-on equipment qualification and validation experience.
• Strong communication and teamwork abilities.

Responsibilities

• Support facility modifications for aseptic processing areas.
• Assist with RABS/ORABS upgrades and readiness activities.
• Support qualification and monitoring of critical utilities (WFI, clean steam, gases, HVAC).
• Execute commissioning, qualification and validation (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.

Skills

Project management

Lean Six Sigma

GMP knowledge

Sterile manufacturing

Data integrity

Problem solving

Teamwork

Education

Bachelor's degree in Engineering

Tools

CQV lifecycle

Automation systems

PLC/SCADA

Qualification protocols

Job description

Viatris in Galway is seeking a Sterile New Product Program Engineer to support a 3-year commercialization program for a new aseptic cartridge-filling line. You will prepare facilities, utilities and equipment for GMP-compliant processes and ensure design, installation, qualification and validation activities align with regulatory requirements for a successful launch.

Reporting to the Strategic Development & Commercialization Lead, you will execute IQ/OQ/PQ, support validation of WFI, clean steam