Biotech MS&T Specialist: Process Eng & NPI

Msd Ireland

Fingal

Hybrid

EUR 70,000 - 100,000

Full time

14 hours ago

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Benefits offered by this job

Hybrid work model

Flexible working arrangements

Job summary

MSD Ireland is seeking a Specialist MS&T to join the Biotech manufacturing site in Dublin. The role will place you in either upstream cell culture or downstream purification, depending on expertise, and focus on sustaining activities, process qualification, and NPI/tech transfer for biologics.

You will support audits, CAPAs, and continuous improvement initiatives, ensuring safety, quality, and reliable supply.

Qualifications

Bachelor-level or higher degree in a relevant science/engineering field.
Experience with upstream cell culture and/or downstream purification of biologics is preferred.
Experience with technology transfer, regulatory filings, and commercial drug substance manufacturing of biologics is desirable.

Responsibilities

Ensure compliance with global policies, procedures and cGMP in day-to-day activities.
Support development and PPQ batches, change control, and CAPA processes.
Assist investigations and root cause analysis; support audits and inspections.
Drive continuous improvement using Lean Six Sigma methodologies.
Lead or support MS&T initiatives in safety, forecasting, and work standardization.
Interpret process data and perform statistical analyses to drive improvements.
Prepare and review batch documentation and technical regulatory submissions.