Senior Pharmaceutical Process Engineer
il y a 4 jours
Job Summary
We are seeking an experienced Process Engineer to join our team at CONSULTYS. 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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