Equipment Engineer II/III

1 week ago

Burbank, United States Recipharm Full time

Reporting to the Manager of Engineering, this new hybrid role combines aspects of both Facilities and Process Engineering at ReciBioPharm’s Manufacturing Facility in Watertown, MA. The position is responsible for maintaining and ensuring the operational efficiency of single-use process equipment such as Tangential Flow Filtration (TFF) skids, bioreactors, Lipid Nanoparticle (LNP) mixing technology, Single Use Mixers, and chromatography skids. Experience with HVAC systems, High Purity Water Systems (WFI), GMP facilities/utilities, grey utilities is desired. This role involves providing comprehensive engineering support for utilities and process equipment, executing/supporting day-to-day operations, troubleshooting, and leading or assisting in various improvement projects. The job will also include participation in the selection, installation, and qualification of new equipment, develop, and maintain standard operating procedures (SOPs), and ensure compliance with GMP regulations and safety standards. Additionally, the role includes conducting investigations of non-conformance events in collaboration with Quality, Tech Transfer, Automation, and Manufacturing teams to identify root causes and implement corrective actions, while supporting continuous improvement initiatives, and operational excellence through effective communication and teamwork. The ideal candidate will possess strong problem-solving skills, excellent collaboration abilities, and experience managing multiple projects in a dynamic environment. Maintain and ensure the operational efficiency of HVAC systems, High Purity Water Systems (WFI), GMP facilities/utilities, and grey utilities. Provide engineering support for the day-to-day operations and troubleshooting of utilities, process/lab equipment, and HVAC systems. Lead or assist in the execution of various projects related process improvements. Conduct investigations into non-conformance events in collaboration with Quality, Automation, and Manufacturing teams to identify root causes and implement corrective actions. Assist Tech Transfer as needed with engineering run design/execution, batch record development. Oversee the operation and maintenance of single-use process equipment, including TFF skids, bioreactors, LNP mixing technology, and chromatography skids. Generate single use component and flow diagrams (SUCFDs) for onboarding new client processes. Participate in the selection, installation, and qualification of new process equipment. Develop and maintain standard operating procedures (SOPs) for process equipment. Ensure compliance with GMP regulations and safety standards for all utilities and process equipment. Collaborate with cross-functional teams to support continuous improvement initiatives and operational excellence. Ensure compliance with GMP guidelines and with all applicable company, federal, and local EH&S regulations, guidelines, and policies. On-site vendor support and relationship management. Education & Experience High School Diploma or equivalent required. Bachelor’s degree in chemical/mechanical engineering preferred. A minimum of 3+ years of experience operating and maintaining process equipment in a medical device or pharmaceutical GMP Environment required. Excellent communication skills, written and verbal Ability to handle multiple priorities simultaneously Solid analytical skills Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus. In the performance of the duties of this job the employee is required to travel occasionally, drive a motor vehicle. Communicate using telephone and e-mail. Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) employing over 5,900 employees worldwide. Recipharm provides manufacturing services of pharmaceuticals in various dosage forms, including, sterile fill & finish, oral solid dosage and biologics; clinical trial material development and manufacturing services; and, pharmaceutical product development. Its biologics segment, ReciBioPharm, works with customers to develop and commercialise advanced therapy medicinal products (ATMPs): pre-clinical to clinical and commercial development and manufacture for new biological modalities, encompassing technologies based on live viruses and viral vectors, live-microbial biopharmaceutical products, nucleic acid-based mRNA and plasmid DNA production.Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. It operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden and the US and is headquartered in Stockholm, Sweden.For more information on Recipharm and our services, please visit and URL to this page #J-18808-Ljbffr

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