Specialist Upstream Operations (m/f/d)

MSD Malaysia; Schachen; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

MSD Malaysia is seeking a Specialist Upstream Operations in Schachen, Switzerland, to support GMP manufacturing and to integrate into an existing team. You will help set up and troubleshoot upstream operations in fed-batch processes while ensuring GMP and EHS compliance and timely documentation of deviations and CAPAs.

You should have 2–5 years in pharma/biotech, GMP biologics experience (upstream or downstream), and strong English and German language skills.

Qualifikationen

• Educational background in a relevant discipline.
• 2–5 years of work experience in the pharmaceutical/biotech industry.
• 2+ years of GMP biologics manufacturing experience (upstream or downstream).
• Expert knowledge of some unit operations in upstream processing of biologics.
• Continuous manufacturing experience is strongly preferred.
• English and German language skills (C1 / B2).

Aufgaben

• Set up, practical execution and troubleshooting of upstream operations in fed-batch processes under GMP.
• Maintain GMP principles and EHS standards in responsibility area.
• Document process execution, deviations, changes and CAPAs.
• Collaborate with QA and other stakeholders during investigations and technical discussions.
• Support implementation of new technologies and non-GMP engineering runs or testing.
• Create and update SOPs and electronic master batch records.
• Review documentation related to process transfer and GMP manufacturing.
• Manage materials using ERP systems (SAP).
• Mentor and train junior team members and participate in knowledge transfer.
• Participate in sampling activities or on-call duties; weekend work may be required.

Kenntnisse

Biologics GMP

Upstream processing

Fed-batch

CAPA

GMP

QA collaboration

SAP

DeltaV

PAS‑X

VeevaVault

English (C1)

German (B2)

Ausbildung

Bachelor’s or Master’s degree in a relevant discipline

Tools

SAP

DeltaV

PAS‑X

VeevaVault

Jobbeschreibung

Job Description Our Schachen serves as a magnetic force that attracts, recognizes, and integrates people from diverse backgrounds and perspectives. Employees feel not only that they belong at Schachen, but that the site belongs to and is shaped by them.

Our Schachen Biotech is a premier, state-of-the-art facility that integrates advanced technologies into the early-stage clinical pipeline, refining them for future commercial launch. The site supports biologics drug substance manufacturing for early-phase clinical supply and serves as a hub for technology innovation and strategic advancement.

The Specialist Upstream Operations position requires full-time physical presence at the site to support manufacturing and to enable optimal integration into an existing team. As a member of the growing manufacturing team at our company, you will be responsible for supporting various activities related to the implementation and GMP manufacturing of early-phase clinical therapies.

Responsibilities

• Set up, practical execution and troubleshooting of upstream operations in fed-batch processes under Good Manufacturing Practices (GMP)
• Knowledge of and compliance to GMP principles and EHS standards in the area of responsibility
• Management and documentation of process execution, deviations, changes and CAPAs.
• Partnering with Quality Assurance and other internal stakeholders during investigations and technical discussions
• Involvement in continuous improvement efforts and support for the implementation of new technologies, including non-GMP engineering runs or testing activities
• Creation and updates of SOPs and (electronic) master batch records.
• Technical review of various documentation related to process transfer and GMP manufacturing
• Material management using ERP systems (SAP)
• Mentoring and training of junior team members, active participation in knowledge transfer
• Participation in sampling activities or on-call duties, which may include weekend work

Your Profile

• Educational background in a relevant discipline
• A minimum of 2-5 years of work experience in the pharmaceutical or biotech industry
• A minimum of 2 years of practical experience in the manufacturing of biologics under GMP, either in upstream or downstream processing
• Expert knowledge of some unit operations in upstream processing of biologics.
• Prior experience with continuous manufacturing is strongly preferred
• Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
• Ability to perform under pressure in a complex GMP environment.
• Business Fluent in English and German: Effective oral / written communication skills in English (C1). Oral / written communication skills in German (B2)

Preferred Experience and Skills

• A bachelor’s or master’s degree in a relevant discipline
• Experience with quality management and compliance systems (SAP QM/VeevaVault).
• Experience with deviation management and development of CAPAs
• Familiarity with the use of automated systems in manufacturing (DeltaV) and electronic batch records (PAS‑X)
• Ability to work efficiently as part of a team, as well as willingness to take responsibility for independent projects

Required Skills

• Accountability, Accountability, Adaptability, Business Agility, Competency Management, Contract Manufacturing, Data Analysis, Deviation Management, Engineering Management, Engineering Standards, Knowledge Sharing, Leadership Training and Development, Manufacturing, Manufacturing Documentation, Manufacturing Processes, Manufacturing Quality Control, Manufacturing Scale-Up, Packaging Engineering, Packaging Equipment, Packaging Processes, Packaging Testing, Pharmaceutical Industry, Pharmaceutical Manufacturing, Pharmaceutics, Process Alignment {+ 10 more}

Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A

Job Posting End Date: 09/29/2026 *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 company is a leading biopharmaceutical company employing over 1,000 people in Switzerland at three sites. The company’s headquarters are in Lucerne. At the site in Zurich, the company operates a global innovation and development hub. In addition, we manufacture medicines for global clinical trials and operate a forensic laboratory in Schachen (Canton Lucerne). We conduct around 40 clinical trials annually in Switzerland. The main therapeutic areas include oncology, infectious diseases, cardiovascular and cardiometabolic diseases. We also have a broad portfolio of vaccines for the prevention of diseases in children, adolescents, and adults and we are one of the leading companies in veterinary medicine. Furthermore, we take our responsibility to the local community seriously and have been involved for many years in initiatives such as the «Trendtage Gesundheit Luzern» and the «Alliance Health Competence». We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us. Our Werthenstein BioPharma site in Schachen is where we conduct cutting‑edge research, develop and analyse new biological agents and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients.