Senior Biologics Process Engineer - Tech Transfer

Merck Gruppe - MSD Sharp & Dohme; Luzern; Hybrid; CHF 130.000 - 190.000; Vollzeit

Zusammenfassung

Merck Gruppe - MSD Sharp & Dohme in the Lucerne area seeks a senior Bioprocess Engineer to lead evaluation, implementation, and qualification of new technologies for biologics development and GMP manufacturing. This on-site role collaborates with local and global teams to advance development and clinical supply.

You will drive technology transfer, process design, risk assessments, and lifecycle documentation while promoting efficiency, compliance, and safety.

Qualifikationen

• Minimum 7 years of experience in the pharmaceutical or biotechnology industry.
• Experience leading projects with cross-functional stakeholders.
• Strong written and verbal communication skills in English (C1) and German (B1).
• Familiarity with automation and digital manufacturing technologies such as MES, DeltaV, SIPAT, PAT and similar systems is an advantage.

Aufgaben

• Lead the evaluation, implementation, and qualification of new technologies, equipment, automation, and digital solutions to advance biologics manufacturing and accelerate technology innovation.
• Provide technical leadership for technology transfer, process improvement, and manufacturing projects, working closely with local and global teams to enable successful GMP batch and continuous manufacturing operations.
• Act as a subject matter expert for process engineering activities, including equipment selection, process design, qualification strategies, risk assessments, and capital investment initiatives.
• Drive the implementation of new manufacturing technologies and ways of working, helping to simplify operations, improve efficiency, and strengthen compliance across the site and network.
• Provide technical leadership for Single-Use Technology (SUT) systems and standards, including strategy development, equipment and component selection, design reviews, change control, risk assessments, Extractables & Leachables (E&L) activities, and lifecycle support from design through qualification and operation.
• Partner with Operations, Quality, Validation, Automation, and Process Development teams to solve complex technical challenges, support investigations, and deliver sustainable process improvements.
• Author, review, and approve key engineering and GMP documentation, including user requirements, capital funding requests, change controls, risk assessments, SOPs, qualification protocols and reports, validation documentation, and technology lifecycle records.
• Support knowledge management, share best practices, and mentor colleagues to strengthen technical capability and engineering excellence while ensuring activities are executed in accordance with GMP, quality, safety, and compliance requirements.

Kenntnisse

Adaptability

Bioprocess Engineering

Deviation Management

Efficiency Improvements

Equipment Qualification

GMP

Manufacturing Processes

Problem Analysis

Process Improvements

Project Leadership

Strategic Thinking

Technical Leadership

Technical Problem-Solving

Tools

MES

DeltaV

SIPAT

PAT

Jobbeschreibung

Merck Gruppe - MSD Sharp & Dohme in the Lucerne area seeks a senior Bioprocess Engineer to lead evaluation, implementation, and qualification of new technologies for biologics development and GMP manufacturing. This on-site role collaborates with local and global teams to advance development and clinical supply.

You will drive technology transfer, process design, risk assessments, and lifecycle documentation while promoting efficiency, compliance, and safety.