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

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

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: 09/19/2026 *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.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.