• Applying fundamental engineering principles to characterize and solve process challenges across multiple unit operations, utilizing both experimental and process simulation/modeling approaches.
• Utilizing appropriate research tools, instrumentation, technologies, and methodologies to support efficient and effective drug product process development
• Assessing processes, taking measurements and interpreting data
• Designing, running, testing and upgrading systems and processes
• Developing best practices, routines and innovative solutions to improve production rates and quality of output
• Performing process simulations and risk assessments while managing cost and time constrains
• Providing process documentation and operating instructions
• Evaluating manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators.
• Developing manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.
• Improving manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
• Assuring product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processes.
• Preparing process reports by collecting, analyzing, and summarizing information and trends.
• Providing manufacturing engineering information by answering questions and requests.
• Completing development projects by training and guiding technicians
Requirements
- Proven work experience as a process engineer min 2 years in pharma industry – a must!
- Strong background in pharmaceutical development as it relates to and process development/optimization.
- Strong background in process development/optimization
- Bachelor’s degree in engineering.
- Working knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design, and statistical process control fundamentals.
- Failure Mode and Effect Analysis (FMEA), Advanced Product Quality Planning (APQP
- Working knowledge of GMPs during pharmaceutical development and commercial manufacturing.
- Programs/Systems: CAD, CAD/CAM, AUTOCAD, SAP (practical experience)
- Practical knowledge of Lean Manufacturing techniques
- Fluent knowledge of English
Additional information
- Attractive salary package
- Flat hierarchies and a collaborative working culture
- Internal and external development opportunities
- Corporate health management
- Group insurance policy
Gerresheimer
Gerresheimer Bünde GmbH is a modern production facility for pre-filled syringe systems and cartridges
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