We are looking for a Process Engineer - II - P2 Specialist, Manufacturing Operations to join the Manufacturing Operations team for one of our clients. This full-time, on-site position is focused on supporting GMP manufacturing activities and ensuring seamless integration within the existing team.
Contract: Temporary contract via Randstad
Start Date: 03/02/2025
End Date: 31/12/2026 (with the possibility of extension)
Location: Schachen, Luzern CH-6105, Switzerland, on-site
Additional Information:
Candidates must either live in the surrounding area or be willing to relocate near Schachen, Luzern.
Responsibilities include but are not limited to:
- Setting up, executing, and troubleshooting upstream, downstream, and support unit operations in continuous and fed-batch manufacturing processes under GMP guidelines.
- Managing documentation for process execution, deviations, changes, and CAPAs while collaborating with Quality Assurance and other internal stakeholders.
- Contributing to continuous improvement initiatives and supporting the implementation of new technologies, including non-GMP engineering runs or testing activities.
- Creating and updating SOPs and electronic master batch records, as well as reviewing technical documentation for process transfer and GMP manufacturing.
- Material management using ERP systems (e.g., SAP).
- Mentoring and training junior team members and actively participating in knowledge transfer.
- Participating in sampling activities or being 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 the ability to work under pressure in a complex environment.
- Fluent English communication skills (C1 level).
- Intermediate German skills (B2 level). Candidates with German A1/B1 proficiency may be considered if other skills strongly align with the role.
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.
If you are interested, please submit your updated CV for consideration.
We are looking for a Process Engineer - II - P2 Specialist, Manufacturing Operations to join the Manufacturing Operations team for one of our clients. This full-time, on-site position is focused on supporting GMP manufacturing activities and ensuring seamless integration within the existing team.
Contract: Temporary contract via Randstad
Start Date: 03/02/2025
End Date: 31/12/2026 (with the possibility of extension)
Location: Schachen, Luzern CH-6105, Switzerland, on-site
Additional Information:
Candidates must either live in the surrounding area or be willing to relocate near Schachen, Luzern.
Responsibilities include but are not limited to:
- Setting up, executing, and troubleshooting upstream, downstream, and support unit operations in continuous and fed-batch manufacturing processes under GMP guidelines.
- Managing documentation for process execution, deviations, changes, and CAPAs while collaborating with Quality Assurance and other internal stakeholders.
- Contributing to continuous improvement initiatives and supporting the implementation of new technologies, including non-GMP engineering runs or testing activities.
- Creating and updating SOPs and electronic master batch records, as well as reviewing technical documentation for process transfer and GMP manufacturing.
- Material management using ERP systems (e.g., SAP).
- Mentoring and training junior team members and actively participating in knowledge transfer.
- Participating in sampling activities or being 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 the ability to work under pressure in a complex environment.
- Fluent English communication skills (C1 level).
- Intermediate German skills (B2 level). Candidates with German A1/B1 proficiency may be considered if other skills strongly align with the role.
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.
If you are interested, please submit your updated CV for consideration.
