Our client in the Biotechnology industry has a new 12 month contract role for an Associate Process Engineer.
General information:
Planned duration: 1 year (Paternity leave)
Work place: Lucern (must also live within a short commute)
Remote/home office: Hybrid
Tasks & Responsibilities:
* Set up, practical execution and troubleshooting of upstream, downstream 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
* 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
* 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
Qualification and Experience
* A bachelor’s or master’s degree in a relevant discipline
* Experience with quality management and compliance systems (Trackwise/SAP QM/VeevaVault)
* Familiarity with the use of automated systems in manufacturing (DeltaV) or electronic batch records (MES)
* Prior experience with process development or process scale-up
* Minimum 2-5 years of work experience in the pharmaceutical or biotech industry
* Hands on experience of 2 years minimum in the manufacturing of biologics under GMP, either in upstream or downstream processing or support operations
* Expert knowledge of some unit operations in upstream or downstream processing of biologics
* Prior experience with continuous manufacturing is desirable, but not required
* Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop
* Business Fluent in English and German
Seniority level
Associate
Employment type
Contract
Job function
Engineering and Manufacturing
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