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.