Sr. Automation Engineer

Paragon BioServices, Inc.
Severn, MD
Jul 21, 2019
Jul 23, 2019
Engineer, IT, QA Engineer
Full Time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. The Sr. Automation Engineer will be part of a team reporting to the VP of IT and will provide key support for various manufacturing, quality and research systems. This will include Programmable Logic controllers (PLC), PI Data Historian, IGNITION for data reporting & remote alarms, Single Use Bioreactors and Other Equipment Manufacturer (OEM) systems in Manufacturing, QC labs and Research Operations. This role will be responsible for trouble-shooting challenging equipment / automation issues to improve manufacturing performance (eg yield improvements, etc.) and maintaining the automation systems in compliance with cGMPs. This role will have the opportunity to lead projects in the deployment of new process and IT capabilities. This role will lead automation-related investigations into Atypical Production Reports (APRs) and implement the corrective actions. Initial responsibilities include working with the startup team and providing technical leadership in fulfilling the automation requirements for a new - $40M GMP Manufacturing facility. For various project assignments/initiatives, the Automation Engineer is responsible for partnering with Quality Assurance and Manufacturing groups in maintaining CGMP requirements. The role provides multiple opportunities to learn new skills in IT, automation and process analytical technologies and help advance innovative gene therapies to patients. Must be able to work and be on call off day shifts including weekends in rotation with other engineers. Key Responsibilities include, but are not limited to: Understands and supports all GMPs, safety, and environmental regulations. Periodically reviews automation documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety. On atypical automation situations, develops and supports corrective actions. Evaluates automated and information technology systems and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, or upgrade. Uses technical knowledge to assure the efficient operation of variety of automated processing and information technology systems. Leads in installing and placing new equipment into operations. Develops solutions for automation problems. Oversees investigations of automation anomalies to prevent recurrence. Participates in audits and training programs for automated systems On-floor support of manufacturing activities. Identify and implement process/equipment improvements and manufacturing efficiencies. Maintain technical documentation. Provides client services support for business area applications. Education & Experience: Bachelor degree in Information Technology, Science, Engineering or related field. Minimum of 7 years experience in an Automation role supporting GMP manufacturing Effective leadership, interpersonal and communication skills (written and oral) are required. A working knowledge of the regulatory requirements for pharmaceutical applications is desirable. Highly desired are skills in PLCs, SCADA, Batch Operations (S88/S95), IT, and OEM equipment. Experience in Process Data Analytics is desired. Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1

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