Senior Biologics Process Engineer — GMP Innovation

MSD UK; Schachen; Vor Ort; CHF 140.000 - 170.000; Vollzeit

Zusammenfassung

MSD UK in the Schachen area near Lucerne seeks a senior Biotech Process Engineer to lead evaluation, implementation, and qualification of advanced equipment, automation, and digital solutions for biologics development and clinical manufacturing. This on-site role collaborates with global teams to advance GMP operations.

You will drive technology transfer, process validation, risk assessments, and lifecycle records while mentoring colleagues and ensuring compliance with GMP, EHS, and quality

Qualifikationen

• Minimum of 7 years of experience in the pharmaceutical or biotechnology industry.
• Experience leading projects with cross-functional stakeholders.
• Strong technical knowledge of biologics manufacturing, including upstream and downstream processing, process development, technology transfer, and process validation.
• Strong understanding of cGMP requirements, EHS expectations, engineering documentation, and quality systems within a regulated environment.
• Experience supporting investigations, CAPA, risk management, and continuous improvement initiatives.
• Familiarity with automation and digital manufacturing technologies such as MES, DeltaV, SIPAT, PAT and similar systems is an advantage.
• Strong written and verbal communication skills in English (C1) and German (B1).

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

Bioprocess Engineering

Equipment Qualification

Process Improvement

Project Leadership

Technical Leadership

Technical Problem-Solving

Adaptability

Problem Analysis

Manufacturing Processes

Strategic Thinking

Deviation Management

GMP

Tools

MES

DeltaV

SIPAT

PAT

Jobbeschreibung

MSD UK in the Schachen area near Lucerne seeks a senior Biotech Process Engineer to lead evaluation, implementation, and qualification of advanced equipment, automation, and digital solutions for biologics development and clinical manufacturing. This on-site role collaborates with global teams to advance GMP operations.

You will drive technology transfer, process validation, risk assessments, and lifecycle records while mentoring colleagues and ensuring compliance with GMP, EHS, and quality