Biotech Process MS&T Specialist (Up/Downstream)

MSD Malaysia; Dublin; Hybrid; EUR 80,000 - 110,000; Full time

Job summary

Merck & Co., Inc.'s Biotech Dublin site is seeking a Specialist MS&T (process engineering & NPI) to support sustaining activities, process qualification, and technology transfer for upstream or downstream biologics manufacturing. The role emphasizes cGMP compliance, QA collaboration and cross-functional troubleshooting.

The successful candidate will contribute to PPQ batches, CAPAs and continuous improvement initiatives while collaborating with manufacturing science, quality and regulatory teams

Qualifications

• Degree in (Bio) Chemistry, Process Technology, Biotechnology, Engineering or comparable.
• Experience with upstream cell culture and/or downstream purification of biological molecules.
• Experience with technology transfer, regulatory filing and commercial drug substance manufacturing of biologics preferred but not essential.

Responsibilities

• Ensure compliance with cGMP in day-to-day activities and all job functions.
• Support development and PPQ batches, change control management and implementation.
• Assist investigations, ensure effective RCA and CAPAs.
• Participate in audits and inspections.
• Support Lean Six Sigma initiatives for site improvements.
• Assist site initiatives to improve compliance and efficiency.
• Support experimental design, data analysis and interpretation.
• Interpret process monitoring trends and support further investigations and changes.

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

Merck & Co., Inc.'s Biotech Dublin site is seeking a Specialist MS&T (process engineering & NPI) to support sustaining activities, process qualification, and technology transfer for upstream or downstream biologics manufacturing. The role emphasizes cGMP compliance, QA collaboration and cross-functional troubleshooting.

The successful candidate will contribute to PPQ batches, CAPAs and continuous improvement initiatives while collaborating with manufacturing science, quality and regulatory teams