Process Operations Engineer (Upstream Operations)

Randstad Switzerland; Luzern; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Randstad Switzerland, on behalf of an international pharmaceutical client, seeks a Process Operations Specialist (Upstream Operations) to join the team on a full-time basis at our Luzern site. The role requires onsite presence to support GMP manufacturing and integration into a growing manufacturing group.

You will set up and troubleshoot upstream and support unit operations in continuous manufacturing and fed-batch processes, contribute to ongoing process improvements, and author SOPs and

Qualifikationen

• Educational background in a relevant discipline.
• A minimum of 0-2 years of work experience in the pharmaceutical or biotech industry.
• Ability to solve problems and take new perspectives with a desire to learn and develop.
• Ability to perform under pressure in a GMP environment and collaborate with stakeholders.
• Business fluent in English and German.
• Residence within commuting distance to Schachen (LU) or willing to relocate.
• Driver’s license (B) and access to a car to enable on-call duties.

Aufgaben

• Set up, practical execution and troubleshooting of upstream and support unit operations in continuous manufacturing and fed-batch processes under GMP.
• Knowledge of and compliance with GMP principles and EHS standards.
• Contribute to continuous improvement and support implementation of new technologies, including non-GMP engineering runs or testing.
• Create and update SOPs and electronic master batch records; perform technical reviews of process transfer and GMP documentation.
• Participate in sampling activities and on-call duties as required by process scheduling; typical manufacturing activities do not include shift work.

Kenntnisse

Problem solving

Continuous learning

Flexibility under pressure

Stakeholder collaboration

Ausbildung

Bachelor's or Master's in a relevant discipline

Educational background in a relevant discipline

Tools

DeltaV

PAS-X

Jobbeschreibung

For one of our clients, an international pharmaceutical company, we are seeking a Process Operations Specialist (Upstream Operations).

General Information:

• Duration: 1 year
• Extension: to be discussed
• Home office: primarily onsite

About the job:

This is an Associate Specialist position within the Process Operations group with a focus on upstream operations. This 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.

Tasks & responsibilities:

• Set up, practical execution and troubleshooting of upstream and support unit operations in continuous manufacturing and fed-batch 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 0-2 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 a bioreactor
• Familiarity with the use of automated systems in manufacturing (DeltaV) and electronic batch records (PAS-X)