Chemical Process Engineer - Life Sciences

Chemical Process Engineer - Life Sciences Maryland Position Overview As a Process Engineer in our Maryland office, you will be at the forefront of clinical and commercial manufacturing execution in the biopharmaceutical industry. In this pivotal role, you will participate in the execution of engineering activities focused on manufacturing processes and equipment—from equipment design and installation through operation and troubleshooting—ensuring our solutions meet the highest standards of quality, efficiency, and performance. You will collaborate with multidisciplinary teams to design, implement, and optimize state‑of‑the‑art manufacturing equipment and automation. Your responsibilities will include improving equipment performance, streamlining process flows, and configuring equipment setups to implement new manufacturing processes. Key Responsibilities Lead the design, development, and execution of projects focused on biopharmaceutical manufacturing processes, ensuring alignment with organizational and client objectives. Develop detailed process control strategies, narratives, and flowpaths to communicate design intent to automation integrators. Implement, troubleshoot, and improve automated manufacturing processes using complex automation systems such as Rockwell, DeltaV, PLC and MES. Implement and troubleshoot large scale manufacturing equipment including process and CIP, SIP of bioreactors, centrifuges and downstream process skidded equipment. Identify, evaluate, and implement process improvements to enhance yield, operational efficiency, and overall manufacturing performance. Collect, analyze, and interpret process data to support design development and process modeling efforts to improve run rates and productivity. Perform technical writing for change controls, deviations, and CAPA summarizing technical items. Ensure strict adherence to project specifications, industry standards, and regulatory requirements throughout the project lifecycle. Participate in Commissioning, Qualification, and Validation (CQV) activities, including Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, and start‑up. Collaborate with cross‑functional teams, including Validation, Manufacturing, Quality, Supply Chain, EHS, and Engineering, to generate user requirements and drive project success. Foster and maintain strong relationships with internal teams, clients, and external vendors to ensure seamless project execution. Facilitate project meetings to drive effective communication, task alignment, and timely decision‑making. Prepare, review, and manage engineering documentation to ensure quality, accuracy, and compliance with industry standards. Support decision‑making by fostering collaboration, consensus, and transparent communication among stakeholders. Advance your technical expertise across multiple biopharmaceutical technologies and modalities, staying at the forefront of industry trends. Develop and enhance your capabilities in project management, capital project delivery, facility construction, validation lifecycles, quality/regulatory compliance, and client relationship management. Commit to continuous professional development by engaging in ongoing learning within the life sciences, maintaining industry‑leading expertise. Minimum Qualifications Bachelor’s degree in chemical engineering or a related field. At least 2 years of experience in the pharmaceutical or biopharmaceutical industry, with a strong focus on GMP (Good Manufacturing Practice) environments. Understanding of process flows in monoclonal antibody (mAb), gene therapy, or cell therapy production. Knowledge of at least one biopharmaceutical manufacturing modality. Ability to lead technical project scopes, including design, execution, and validation phases. Strong knowledge of engineering principles, GMP requirements, and industry best practices. Excellent verbal and written communication skills, with the ability to convey complex technical concepts to diverse audiences. Skilled in managing time effectively, prioritizing tasks, and meeting deadlines in a fast‑paced environment. Flexibility and willingness to travel within Maryland as required based on project locations and client needs. Beneficial Qualifications 5 years of engineering experience in a cGMP-regulated industry, with a thorough understanding of regulatory requirements and industry standards. Proficiency in automation and control systems, including hands‑on experience within manufacturing environments. Deep knowledge in at least two biopharmaceutical manufacturing modalities, such as mAb, gene therapy, or cell therapy. Experience in designing, starting up, shutting down, returning to service, and troubleshooting biopharmaceutical manufacturing systems. Proven project management skills, with experience in capital projects. Willingness to travel within the United States as required based on project locations and client needs. #J-18808-Ljbffr AllianceBIO LLC