Ingeniero de Procesos Biofarmacéuticos Sr.

About the Role

Our client, a rapidly growing biopharmaceutical company, is seeking a highly experienced Ingeniero de Procesos Biofarmacéuticos Sr. to join their manufacturing operations in Tijuana, Baja California, MX . This role is crucial for the development, optimization, and scale-up of biopharmaceutical manufacturing processes, including upstream (cell culture) and downstream (purification) operations. The ideal candidate will possess a deep understanding of bioreactor technology, cell culture optimization, protein purification techniques, and process validation. You will work closely with manufacturing, quality control, and R&D teams to ensure the efficient and compliant production of high-quality biological products. Your expertise will be vital in ensuring process robustness, yield improvement, and regulatory adherence. We are looking for a hands-on engineer with a strong track record in bioprocess development and manufacturing.

Key Responsibilities

• Lead process development and optimization efforts for upstream and downstream biopharmaceutical manufacturing.
• Scale-up manufacturing processes from laboratory to pilot and commercial scales.
• Develop and execute process validation strategies and protocols.
• Troubleshoot and resolve complex process-related issues encountered during manufacturing.
• Identify opportunities for process improvement to enhance yield, efficiency, and reduce costs.
• Ensure all process development and manufacturing activities comply with GMP and regulatory requirements.
• Author technical reports, process descriptions, and documentation for regulatory submissions.
• Collaborate with cross-functional teams, including R&D, QC, QA, and Manufacturing.
• Stay abreast of new technologies and methodologies in biopharmaceutical process development.

Requirements

• Bachelor's or Master's degree in Chemical Engineering, Bioengineering, Biotechnology, or a related field.
• Minimum of 6 years of experience in biopharmaceutical process development and/or manufacturing.
• Strong experience with mammalian cell culture (upstream) and protein purification (downstream) processes.
• Proficiency in process scale-up, technology transfer, and process validation.
• In-depth knowledge of GMP regulations and their application in biopharmaceutical manufacturing.
• Experience with process modeling and simulation tools is a plus.
• Excellent analytical, problem-solving, and project management skills.
• Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
• Must be willing to work on-site in Tijuana, Baja California, MX.

Benefits

• Our client offers a competitive salary, comprehensive health benefits, and opportunities for professional growth within a dynamic and expanding company.
• This on-site role provides the chance to work with cutting-edge biopharmaceutical manufacturing technology in the thriving region of Tijuana, Baja California, MX.
• You will contribute to the production of vital therapies and have a direct impact on patient well-being.
• We offer a collaborative work environment and ongoing training.
• Paid time off and performance bonuses are part of the compensation package.
• Join a team dedicated to advancing biopharmaceutical manufacturing.