Senior Pharmaceutical Process Engineer

3 weeks ago

Copenhagen, Copenhagen, Denmark AM Group Full time

AM Group - partner of Consultys - is a consulting company based on experience and a desire to challenge the norm.

We believe in approaching consulting differently.

Instead of relying on complex theories that only work in ideal scenarios, we utilize well-established management and engineering tools to deliver tangible improvements to our clients' businesses.

We bring the experience to know when to do what and we do it with your people so they can learn and take over when our job is done. AM Group is short for 'Applied Management' – and that is what we do. We apply simple, reliable management tools to improve our clients' business.

Job Summary

We are seeking an experienced Process Engineer 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.
  • Proficiency 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.
Seniority level

Associate

Employment type

Full-time

Job function

Quality Assurance, Manufacturing, and Engineering

Industries

Business Consulting and Services, Pharmaceutical Manufacturing, and Biotechnology Research

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