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Process Engineer - Carlsbad, United States - Consultys
3 weeks ago
Description
MissionsWe 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.
ResponsibilitiesCollaborate 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.
Requirements
Bachelor's or Master's degree in Chemical Engineering, Bioprocess Engineering, or a related field.
Minimum of 2-5 years of process engineering experience in one of the following life sciences industries: pharmaceuticals, medical devices, food and beverage, cosmetics.
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.
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