Senior Pharmaceutical Process Engineer

Vor 2 Tagen


Frankfurt, Deutschland CONSULTYS Vollzeit

This opportunity requires long-term relocation to the Copenhagen area in Denmark.



Job Summary


We are seeking an experienced Process Engineer experienced in the life sciences industry to join our team. As a Process Engineer, you will play a key role in designing, optimizing, and overseeing processes to ensure the highest quality and efficiency in the production of multiple types of pharmaceutical products.



Responsibilities


  • Collaborate with cross-functional teams to design, develop, and optimize manufacturing processes in the life sciences industry.
  • Conduct process simulations, evaluate and implement process improvements, and troubleshoot operational issues.
  • Participate in the development and review of process documentation, including P&IDs, standard operating procedures, and batch records.
  • Ensure processes comply with industry-specific regulations and standards, such as cGMP, FDA, and other relevant guidelines.
  • Provide technical expertise in areas like aseptic processing, downstream and upstream processing, filtration, sterilization, and purification techniques.
  • Lead or support process validation activities to ensure product quality and regulatory compliance.
  • Investigate deviations, incidents, and quality issues, and propose corrective and preventive actions.
  • Collaborate in the scale-up and technology transfer of processes from development to commercial production.
  • Support equipment selection, qualification, and maintenance activities.
  • Keep abreast of industry trends and advancements to drive continuous improvement in processes and technologies.



Qualifications


  • Bachelor's or Master's degree in Chemical Engineering, Bioprocess Engineering, or a related field.
  • Minimum of 5 years of process engineering experience in the pharmaceutical or biopharmaceutical industry.
  • Skilled in process modeling and simulation tools.
  • Strong analytical and problem-solving skills.
  • Excellent written and verbal communication abilities.
  • Ability to work effectively within cross-functional teams and independently.
  • Experience with process validation, technology transfer, and equipment qualification is a plus.


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