Senior Process Engineer – Biotech Process Engineering (m/f/d)

MSD Switzerland; Ruswil; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

MSD Switzerland in Lucerne region seeks a senior Bioprocess Engineer to advance biologics manufacturing. You will lead evaluation, implementation, and qualification of innovative equipment and processes, partnering with global teams to bring new technologies into GMP operations.

The role focuses on technology transfer, process development, and driving compliant, efficient manufacturing while strengthening engineering excellence onsite.

Qualifikationen

• Minimum 7 years of experience in pharma/biotech industries.
• Experience leading projects with cross-functional stakeholders.
• Strong knowledge of biologics manufacturing and process development.
• Solid understanding of cGMP, EHS, and quality systems.

Aufgaben

• Lead evaluation, implementation, and qualification of new technologies and equipment for biologics manufacturing.
• Provide technical leadership for technology transfer, process improvements, and GMP projects.
• Act as SME for process engineering activities including design, qualification strategies, and risk assessments.
• Drive adoption of new manufacturing technologies and ways of working to simplify operations and enhance compliance.
• Lead Single-Use Technology (SUT) systems, including lifecycle support from design to operation.
• Collaborate with Operations, Quality, Validation, Automation, and Process Development teams to solve complex technical challenges.

Kenntnisse

Bioprocess Engineering

Process Development

Technology Transfer

GMP Documentation

Automation & Digital Manufacturing

Tools

DeltaV

SIPAT

PAT

MES

Jobbeschreibung

Job Description

Located in the greater Lucerne area, the company`s Schachen Biotech facility is a state-of-the-art manufacturing and innovation hub supporting early-phase clinical supply for biologics and the introduction of new technologies into our development pipeline. The facility combines advanced manufacturing capabilities with a collaborative culture, enabling close partnership across teams, functions, and the global company network.

Job Description

Located in the greater Lucerne area, the company`s Schachen Biotech facility is a state-of-the-art manufacturing and innovation hub supporting early-phase clinical supply for biologics and the introduction of new technologies into our development pipeline. The facility combines advanced manufacturing capabilities with a collaborative culture, enabling close partnership across teams, functions, and the global company network.

As part of the growing Biotech Process Engineering team, you will play a key role in advancing biologics manufacturing. In this senior, on-site position, you will lead the evaluation, implementation, and qualification of innovative equipment, processes, and next-generation technologies supporting development and clinical manufacturing. Working closely with local and global colleagues, you will help bring new technologies into GMP operations while driving safe, compliant, and efficient manufacturing processes.

This role offers a unique opportunity to influence the introduction of new manufacturing technologies, collaborate with experts across the global company network, and contribute directly to the future of biologics development and clinical manufacturing.

Responsibilities

• 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.

Required Experience And Skills

• 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.
• A collaborative and proactive working style, with the ability to work effectively both independently and within cross-functional teams.
• Strong analytical and practical problem-solving skills, with the ability to challenge existing approaches and identify effective solutions.
• Strong written and verbal communication skills in English (C1) and German (B1).

Required Skills

Adaptability, Bioprocess Engineering, Deviation Management, Efficiency Improvements, Equipment Qualification, Good Manufacturing Practices (GMP), Manufacturing Processes, Problem Analysis, Process Improvements, Project Leadership, Strategic Thinking, Technical Leadership, Technical Problem-Solving

Preferred Skills

Knowledge Transfer, Process Manufacturing

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

No Travel Required

Flexible Work Arrangements

Not Applicable

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

• A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R415043