There is a life sciences revolution occurring being driven by the tremendous demand for cell and gene therapies. This demand coupled with the desire for collaboration, the availability of capital, regulatory mind shifts, technological developments, and bottlenecks in supply chains are creating tremendous opportunities for first movers and service providers. The Discovery Labs platform supports and drives this new environment by creating space for CGT Manufacturing, Research and Discovery and the all supporting services.
Provide support for various manufacturing, quality and analytical testing systems. These include industrial control systems, lab equipment, and analytical instruments as well as site and enterprise systems (i.e. MES, PLM, BMS, EMS) for the management of operations, quality, and process development.
This role will be responsible for trouble-shooting challenging equipment / automation issues to improve manufacturing performance (e.g. 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.
For various project assignments/initiatives, the Sr. 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 cell and gene therapies to patients.
Understands and supports all GxP environments.
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 and helps develop training programs for automated systems
Provides on-floor support of manufacturing activities.
Identifies and implements process/equipment improvements and manufacturing efficiencies.
Maintains technical and quality documentation.
Provides client services support for business area applications.
Preferred Experience in:
Basics of networking
Server administration, including virtualization
Experience with data historian, SCADA, PLC and various other industrial automation technologies
Familiar with equipment: Single Use Bioreactors and Other Equipment, QC Equipment and Research Operations.
Education & Experience:
B.S., B.A, or M.S. in Information Technology, Science, Engineering or related field.
Minimum of 5 years experience in an Automation role supporting GMP manufacturing
Effective leadership, interpersonal and communication skills (written and oral) are required.
A working knowledge of regulatory requirements for pharmaceutical applications is highly desirable.
Highly desired are skills in PLCs, SCADA, Batch Operations (S88/S95), IT, and OEM equipment.
Experience in Process Data Analytics is desired.