Sterile Process Engineer – Technical Services

QCS Staffing; Galway; On-site; EUR 52,000 - 70,000; Full time

Job summary

A Process Engineer (Technical Services) is needed in Galway, Ireland, to join a global pharmaceutical manufacturing facility on a 6-month contract. You will support sterile manufacturing processes, assist with validation and PPQ/CPV protocols, and contribute to technology transfer and NPI activities on site.

You will lead deviation investigations, root cause analysis for GMP compliance, and help drive process improvements.

Qualifications

• Proven experience in sterile / aseptic pharmaceutical manufacturing.
• Hands on experience with process validation (PPQ/CPV) in a GMP environment.
• Strong capability in writing protocols, reports, and technical documentation.
• Extensive experience in process engineering, MSAT, or technical services within pharma manufacturing.

Responsibilities

• Support the development, optimisation, and troubleshooting of sterile pharmaceutical manufacturing processes
• Author and execute process validation documentation including PPQ/CPV protocols and reports
• Support technology transfer and new product introduction (NPI) activities across site
• Lead deviation investigations and root cause analysis to ensure GMP compliance and process improvement

Skills

Sterile manufacturing

Process validation PPQ/CPV

Technical documentation writing

MSAT/technical services

Job description

A Process Engineer (Technical Services) is needed in Galway, Ireland, to join a global pharmaceutical manufacturing facility on a 6-month contract. You will support sterile manufacturing processes, assist with validation and PPQ/CPV protocols, and contribute to technology transfer and NPI activities on site.

You will lead deviation investigations, root cause analysis for GMP compliance, and help drive process improvements.