Biotech MS&T Process Engineer — Lean Six Sigma & GMP

MSD; Fingal; Hybrid; EUR 70,000 - 100,000; Full time

Job summary

MSD in Dublin seeks a skilled professional to join its Biotech manufacturing science & technology team. You will ensure cGMP compliance, support development and PPQ batches, and assist investigations with root cause analysis and CAPAs.

You'll participate in audits, apply Lean Six Sigma to drive continuous improvement, and collaborate with regulatory, quality, analytics and manufacturing groups to secure product quality and process robustness.

Qualifications

• Degree in (Bio) Chemistry, Process Technology, Biotechnology, Engineering or comparable.
• Experience with upstream cell culture and/or downstream purification of biological molecules.
• Experience in change management, deviations and CAPAs management (desirable)

Responsibilities

• Ensure cGMP compliance and regulatory requirements in day-to-day activities.
• Support development and PPQ batches, change control management and implementation.
• Assist investigations, root cause analysis and CAPAs.
• Participate in audits and inspections.
• Support Lean Six Sigma and continuous improvement initiatives.
• Lead cross-functional MS&T initiatives and support process improvements.
• Apply Lean Six Sigma tools and lead FMEA projects.

Skills

CAPA Investigations

Cell Cultures

Manufacturing Operations

Process Control

Six Sigma

Technology Transfer

Education

Degree in (Bio) Chemistry, Process Technology, Biotechnology, Engineering or comparable

Job description

MSD in Dublin seeks a skilled professional to join its Biotech manufacturing science & technology team. You will ensure cGMP compliance, support development and PPQ batches, and assist investigations with root cause analysis and CAPAs.

You'll participate in audits, apply Lean Six Sigma to drive continuous improvement, and collaborate with regulatory, quality, analytics and manufacturing groups to secure product quality and process robustness.