You play a crucial role in supporting biopharmaceutical production processes, ensuring compliance and efficiency. This includes hands-on coordination, training, and managing the transition of products from development to manufacturing.
Anforderungen
- •Bachelor's degree in a relevant field
- •Knowledge of GMP
- •Fluent in English and German
- •Experience in the pharmaceutical industry preferred
- •Proficient technical writing experience
- •Experience with root cause investigations
- •Experience working with cross-functional teams
Deine Aufgaben
- •Coordinate and support biopharmaceutical production.
- •Assist in drug product compounding and sterile filling.
- •Prepare supporting documents for production and inspections.
- •Provide real-time support for shop floor operations.
- •Manage and collaborate on production improvement projects.
- •Conduct training for personnel on hygiene and safety.
- •Control technical execution and interpret study results.
- •Handle deviations and coordinate required actions.
- •Support transfer of new products to manufacturing.
Deine Vorteile
Market-competitive base salary
Attractive incentive program
Modern company pension scheme
Childcare facilities
Learning and development opportunities
Worldwide career possibilities
Original Beschreibung
# Process Expert (m/f/d), Schaftenau, Tyrol Austria
**Schaftenau** | **Full time**
**Band**
Level 3
**Job Description Summary**
Location: Schaftenau, Tyrol, #LI-Hybrid
We are currently seeking a highly skilled Process Expert (m/f/d) to join our team in Schaftenau, Tyrol. This role is integral to ensuring the efficient execution of processes and fostering continuous improvements in quality, productivity, and efficiency.
The successful candidate will work closely with the Process Support Unit and report directly to the Senior Process Expert Team Lead. Key responsibilities will include analyzing and optimizing process workflows, implementing best practices, and contributing to strategic initiatives aimed at enhancing operational performance.
**Job Description**
**Key Responsibilities:**
* Provide support in the coordination and production of biopharmaceuticals as well as in GMP processes.
* This role will support drug product compounding, sterile filling, and aseptic processing unit of the Drug Product Schaftenau DP1 manufacturing unit.
* Preparation of production supporting documents, as well as for internal and regulatory inspections.
* Ensure real time shop floor support and the completion of production operations on time, in accordance with the documentation and in compliance with GMP, SSE and 5S rules.
* Collaboration and management of improvement projects in the production environment.
* Preparation / execution of training for production personnel regarding industrial hygiene, GMP and safety.
* Technical control of the execution / interpretation of study results as well as provision and evaluation of process relevant data.
* Handling of deviations, implementation / coordination of defined actions as well as implementation of approved change requests.
* Supporting the transfer of new biopharmaceutical products from development into the manufacturing site.
**Essential Requirements:**
* Completed studies in the field of Process Engineering, Biotechnology, Biology, Pharmaceutical Technology, Technical Chemistry, Pharmacy (or comparable studies), min. Bachelor's degree.
* GMP knowledge.
* Proficiency in English and German (spoken & written).
* Desirable Requirements:
* Previous experience in the pharmaceutical industry, preferably manufacturing of large molecules, development, Quality Assurance or Quality Control.
**Desirable Requirements**:
* Proficient technical writing experience.
* Previous experience with conducting root cause investigations and defining corrective actions for process improvement.
* Previous experience collaborating and working with diverse cross-functional teams.
**Skills Desired**
Cross-Functional Teamwork, Good Manufacturing Practices (GMP), Manufacturing, Pharmaceutical Industry, Process Improvements, Process Support, Technical Writing