Process Engineer

 
Mid-level
🇵🇱 Poland
Operations

• 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

Gerresheimer Bünde GmbH is a modern production facility for pre-filled syringe systems and cartridges

🏥Good health and wellbeing
Medical Devices
Pharmaceuticals
Manufacturing

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