Senior Process Engineer, Pharmaceuticals

Our client is a leading pharmaceutical company seeking a highly skilled Senior Process Engineer to join their innovative team in San Francisco, California, US . This critical role involves optimizing and scaling up chemical processes for pharmaceutical manufacturing, ensuring efficiency, quality, and compliance with stringent regulatory standards. You will be responsible for process design, troubleshooting, validation, and continuous improvement initiatives. The ideal candidate possesses a strong background in chemical engineering principles applied to pharmaceutical production, with extensive experience in process development, scale-up, and GMP environments. Responsibilities include:

Designing, developing, and optimizing chemical processes for the manufacturing of pharmaceutical intermediates and active pharmaceutical ingredients (APIs). Leading process scale-up activities from laboratory to pilot plant and commercial production. Troubleshooting and resolving process-related issues to ensure consistent product quality and yield. Developing and executing process validation protocols (IQ, OQ, PQ) in accordance with regulatory guidelines. Collaborating with R&D, manufacturing, quality assurance, and regulatory affairs teams to ensure successful process transfer and implementation. Conducting process hazard analyses (PHAs) and implementing safety measures. Implementing process control strategies and utilizing statistical process control (SPC) techniques. Identifying and evaluating new technologies and equipment for process improvement. Authoring and reviewing technical documents, including batch records, SOPs, and technical transfer reports. Ensuring all activities comply with Good Manufacturing Practices (GMP) and other relevant regulatory requirements (FDA, EMA). Mentoring junior engineers and contributing to the technical development of the team. Managing external resources and vendors related to process development and equipment. Developing and managing project timelines and budgets for process engineering initiatives. Evaluating and recommending process improvements to enhance efficiency, reduce costs, and minimize environmental impact. Staying current with industry trends, scientific advancements, and regulatory changes.

Qualifications:

Master's degree or Ph.D. in Chemical Engineering or a closely related field. Minimum of 7 years of experience in process development and engineering within the pharmaceutical or biotechnology industry. Extensive knowledge of GMP regulations and validation principles. Proven experience in process scale-up, technology transfer, and manufacturing support. Proficiency in process simulation software (e.g., Aspen Plus) and statistical analysis tools. Strong understanding of reaction engineering, separation processes, and crystallization. Excellent problem-solving, analytical, and critical thinking skills. Superior communication, presentation, and interpersonal skills. Ability to lead cross-functional teams and manage complex projects. Experience with process safety management and risk assessment. Familiarity with continuous manufacturing concepts is a plus.

This is a high-impact role offering significant opportunities for professional growth and contribution to life-saving medicines.