Beschreibung

Specialist Manufacturing Processes Fill & Finish
Mainz, Germany | full time | Job ID:9291

Are you ready to take on responsibilities with continuous support from your diverse and collaborative team and manager, while enjoying an independent work style free from micromanagement?

At the individualized neoantigen specific therapy facility, cancer therapeutics will be produced individually for each patient in order to meet their personal needs.

The role of Specialist Manufacturing Processes - Fill & Finish supports the daily operations in production to enable smooth production. As support for the subject matter experts (SMEs), the role holder possesses in-depth process knowledge in
the areas of aseptic filling, sterilization and decontamination and is familiar with Single Use Systems (SUS). You will also have the opportunity to participate in projects (OPEX and/or CAPEX) in collaboration with process development, the clinical production department, engineering and maintenance, Quality Control, Supply Chain Management or other departments. Or you may even become a project manager yourself.

Tasks include root cause analysis and risk assessment for process deviations and the definition of corrective and preventive Actions. The Specialist Manufacturing Processes - Fill & Finish further more coordinates change control.
Supporting SMEs in terms of product, process and equipment knowledge to produce individualized cancer therapies
Initiation and processing of deviations and related investigations
Creation / editing / coordination of department/ module-specific documents (e.g. SOPs, forms)
Support in creating and regularly updating the Master Batch Records (MBRs) for the department
Creation / processing / coordination of qualification of equipment and process validation as well as documents
Support and KeyUser Function in setting up digital production systems (e.g. eQMS, SAP, MES)
Definition, implementation and processing of corrective and preventive actions (CAPA management/ Implementor)
Responsible for initiating, planning, evaluating, processing, and implementing of changes (change owner)
Performs function as: Equipment Responsible Person, Qualification Responsible Person, Key User
Support of the SME in the TechTransfer, Qualification or Validation

Relevant scientific or technical vocational training (e.g., BTA, CTA, PTA or equivalent experience) or a relevant higher academic degree (e.g., Bachelor Professional, State-certified technical engineer, B.Sc., M.Sc., Diploma, PhD, or Dr.) forms the foundation for this role. Advanced degrees or additional qualifications are welcome but not mandatory
Several years of relevant professional experience (typically >3 years), ideally in aseptic manufacturing/production or a related field, preferably in a biotech or pharmaceutical company, are expected. Alternatively, highly qualified graduates with relevant academic backgrounds are encouraged to apply.
Experience with digital manufacturing solutions (e.g., LIMS, PCS, MES, ERP) and eQMS is beneficial and will help you excel in this role
General understanding of technical processes and a strong interest in contributing to innovative production methods
Solid GMP knowledge (e.g., EU GMP Guidelines, Annex 1, Guidelines for ATMPs, FDA cGMP Regulations) is advantageous
A high level of carefulness and accuracy in your work, combined with conscientiousness and attention to detail, is essential
A strong commitment to BioNTech's mission of revolutionizing medicine and to the responsibilities of the role, combined with a collaborative mindset and the ability to work reliably within a team. As a key team member, others will rely on your expertise and dedication in taking ownership of tasks and driving them forward
Fluency in written and spoken German and English, along with refined colloquial and correspondence skills in both languages, rounds off your profile
It's our priority to support you:

Your flexibility: flexible hours | vac...