Senior Biotech Process Engineer: Tech Transfer & Innovation

MSD Malaysia; Schachen; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

MSD Malaysia in Lucerne-Schachen is seeking a Sr. Biotech Process Engineer to lead evaluation, implementation, and qualification of innovative equipment and technologies for biologics development and GMP manufacturing.

You will partner with global teams to advance technology transfer and ensure compliant, efficient operations. The role requires senior expertise in upstream/downstream processing, cGMP, and risk-based qualification strategies, with strong leadership and cross-functional

Qualifikationen

• 7+ years in pharmaceutical/biotech sector.
• Experience leading cross-functional projects.
• Strong biologics manufacturing knowledge (upstream/downstream).
• Understanding of cGMP, EHS, QA systems in regulated env.
• Experience with investigations, CAPA, risk management.
• Familiarity with MES/automation & digital tech is a plus.
• Fluent English (C1) and German (B1).

Aufgaben

• Lead evaluation, implementation, and qualification of new technologies and equipment.
• Provide technical leadership for technology transfer and manufacturing projects.
• Act as SME for process engineering activities including qualification strategies and risk assessments.
• Drive adoption of new manufacturing tech and simplify operations.
• Lead SUT systems strategy, design reviews, change control, and lifecycle support.
• Collaborate with Operations, Quality, Validation, Automation, and Process Development teams.
• Author and review GMP docs including URs, CAPAs, change controls, and validation docs.
• Mentor colleagues to strengthen engineering capability and GMP compliance.

Kenntnisse

Bioprocess Eng

Project Leadership

Process Development

Technology Transfer

GMP Compliance

Equipment Qualification

Cross-functional Collaboration

cGMP Knowledge

Problem Solving

Digital Manufacturing

Tools

MES

DeltaV

SIPAT

PAT

Jobbeschreibung

MSD Malaysia in Lucerne-Schachen is seeking a Sr. Biotech Process Engineer to lead evaluation, implementation, and qualification of innovative equipment and technologies for biologics development and GMP manufacturing.

You will partner with global teams to advance technology transfer and ensure compliant, efficient operations. The role requires senior expertise in upstream/downstream processing, cGMP, and risk-based qualification strategies, with strong leadership and cross-functional