Job Description:
We are seeking a highly skilled Process Engineer II - P2 Specialist, Manufacturing Operations, to support our client's GMP manufacturing activities. This full-time, on-site position involves ensuring seamless integration within the existing team.
About the Role:
This Temporary contract via Randstad offers an ASAP start date and the possibility of extension until 31/12/2026. The successful candidate will be based in Schachen, Luzern CH-6105, Switzerland, on-site.
Responsibilities:
* Set up, execute, and troubleshoot upstream, downstream, and support unit operations in continuous and fed-batch manufacturing processes under GMP guidelines.
* Manage documentation for process execution, deviations, changes, and CAPAs while collaborating with Quality Assurance and other internal stakeholders.
* Contribute to continuous improvement initiatives and support the implementation of new technologies, including non-GMP engineering runs or testing activities.
* Create and update SOPs and electronic master batch records, as well as review technical documentation for process transfer and GMP manufacturing.
* Manage material using ERP systems (e.g., SAP).
* Mentor and train junior team members and actively participate in knowledge transfer.
* Participate in sampling activities or be on-call, including potential weekend duties.
Requirements:
* Educational background in a relevant discipline.
* 2-5 years of experience in the pharmaceutical or biotech industry.
* Minimum of 2 years of practical experience in the GMP manufacturing of biologics (upstream or downstream).
* Expert knowledge in specific unit operations for biologics manufacturing.
* Understanding of GMP principles and ability to work under pressure in a complex environment.
* Fluent English communication skills (C1 level).
* Intermediate German skills (B1 level).
Preferred Skills and Experience:
* Bachelor's or Master's degree in a relevant discipline.
* Familiarity with quality management and compliance systems (e.g., Trackwise, SAP QM, VeevaVault).
* Experience with automated systems (DeltaV) or electronic batch records (MES).
* Previous experience with process development or scale-up activities.
* Ability to work efficiently as part of a team and independently on projects.