Process Engineer (Downstream Operations)

Randstad Switzerland; Luzern; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Randstad Switzerland is assisting an international pharmaceutical client in finding an Associate Process Specialist - Downstream Operations for a 12‑month, onsite assignment in the Lucerne region. The role requires full-time presence at site to integrate into the team and support GMP manufacturing.

The candidate will work on downstream processing, SOPs, batch records, and process improvements, and must have 1–2 years in pharma/biotech with English and German fluency, plus a valid driving license

Qualifikationen

• 1–2 years of pharma/biotech experience.
• Ability to solve problems in a GMP environment.
• Willingness to learn and adapt with stakeholders.

Aufgaben

• Set up and troubleshoot downstream processes under GMP.
• Maintain GMP/EHS compliance and SOP master records.
• Support process transfers, documentation reviews, and batch records.
• Participate in sampling activities and on-call duties as needed.

Kenntnisse

English

German

Ausbildung

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

Tools

DeltaV

PAS-X

Jobbeschreibung

For one of our clients, an international pharmaceutical company, we are seeking an Associate Process Specialist - Downstream Operations.

General Information:

• Duration: 12 months
• Home office: not possible, 100% onsite
• Working hours: Standard

About the work:

As a member of the manufacturing team, you will be responsible for supporting various activities related to the implementation and GMP manufacturing of early-phase clinical therapies.

This position requires full-time physical presence at the site to support manufacturing and to enable optimal integration into an existing team.

Tasks & responsibilities:

• Set up, practical execution and troubleshooting of downstream processes under Good Manufacturing Practices (GMP)
• Knowledge of and compliance to GMP principles and EHS standards in the area of responsibility
• 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
• Participation in sampling activities (including occasional weekend work) or on-call duties, as required by the process scheduling. Typical manufacturing activities do not include shift work.

Requirements:

• Educational background in a relevant discipline
• A minimum of 1-2 years of work experience in the pharmaceutical or biotech industry.
• 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 and assume responsibility. Flexible attitude when working with internal or external stakeholders to achieve ambitious targets.
• Business Fluent in English and German.
• Residence within approximately 30 minutes commuting distance from Schachen (LU) or willingness to relocate.
• Driver’s license (B) and access to a personal car to enable on-call duties.

Preferred Experience and Skills:

• A bachelor’s or master’s degree in a relevant discipline
• Prior experience in the manufacturing of biologics under GMP, ideally including experience operating capturing and polishing chromatography, virus filtration, UFDF, formulation, fill & freeze
• Familiarity with the use of automated systems in manufacturing (DeltaV) and electronic batch records (PAS-X)