Job Description:
We are seeking a skilled Process Engineer - II - P2 Specialist, Manufacturing Operations to support our client's GMP manufacturing activities.
This is a full-time, on-site position focused on ensuring seamless integration within the existing team.
The ideal candidate will have experience in upstream, downstream, and support unit operations in continuous and fed-batch manufacturing processes under GMP guidelines.
A key responsibility of this role will be managing documentation for process execution, deviations, changes, and CAPAs while collaborating with Quality Assurance and other internal stakeholders.
The successful candidate will also contribute to continuous improvement initiatives and support the implementation of new technologies, including non-GMP engineering runs or testing activities.
A strong educational background in a relevant discipline and 2-5 years of experience in the pharmaceutical or biotech industry are required.
Expert knowledge in specific unit operations for biologics manufacturing and understanding of GMP principles are essential.
Familiarity with quality management and compliance systems, automated systems, and electronic batch records is preferred.
The ability to work efficiently as part of a team and independently on projects is crucial.
Fluent English communication skills (C1 level) and intermediate German skills (B1 level) are necessary.
* Responsibilities:
* 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 (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.