Senior Process Engineer Specialist

QCS Staffing; Dublin; On-site; EUR 85,000 - 115,000; Full time

Job summary

QCS Staffing Ltd seeks a Senior Process Engineer Specialist to support biologics manufacturing in Dublin. The role covers upstream cell culture and downstream purification, technology transfer and process performance monitoring

The ideal candidate holds MSc or equivalent in biotechnology or related field with strong GMP and MSAT experience. This is an initial 11‑month contract based in Ireland.

Qualifications

• Experience in biotechnology/pharma manufacturing, process engineering, MSAT or technical operations.
• Knowledge of biologics manufacturing processes, including upstream cell culture and downstream purification.
• GMP regulations, process validation, quality systems, deviation management and change control.
• Experience with process monitoring tools CPV, SPC, MVDA and PAT; proficiency in JMP or Design Expert.

Responsibilities

• Support design, construction, qualification and startup of upstream and downstream biologics manufacturing equipment.
• Support technology transfer and commercialisation activities for biologics processes.
• Monitor process performance using CPV, SPC, MVDA and PAT to identify trends and drive improvements.
• Support investigations, deviations, change controls, process validation and continuous improvement initiatives.

Education

MSc Biotechnology

Tools

JMP

Design Expert

Job description

Senior Process Engineer Specialist – Dublin, Ireland – Initial 11-Month Contract – Life Sciences

Our client is a global leader in pharmaceutical innovation, specialising in the development and manufacture of cutting‑edge drugs. As they continue to grow, they’re seeking an experienced Senior Process Engineer Specialist to support their dynamic team and drive forward groundbreaking projects in Dublin.

What you’ll deliver:

• Support the design, construction, qualification, and startup of upstream and downstream biologics manufacturing equipment.
• Support technology transfer and commercialisation activities for biologics manufacturing processes.
• Monitor process performance using CPV, SPC, MVDA, and PAT methodologies to identify trends and drive improvements.
• Support process investigations, deviations, change controls, process validation, and continuous improvement initiatives.

What you’ll need:

• Extensive experience (MSc) or (BSc) experience within biotechnology, pharmaceutical manufacturing, process engineering, MSAT, or technical operations.
• Strong understanding of biologics manufacturing processes, including upstream cell culture and/or downstream purification.
• Extensive knowledge of GMP regulations, process validation, quality systems, deviation management, and change control.
• Experience with process monitoring tools such as CPV, SPC, MVDA, PAT, and statistical analysis software including JMP or Design Expert.