Sr Automation Engineer

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

The Senior Automation Engineer is a technical position that directly supports operations. The role provides automation engineering support for process, facility, and/or utility control systems used in the manufacture of biopharmaceuticals. The scope of support includes process data historians, processing, and/or building management system controls. This role supports end users in diagnosing, repairing, and upgrading control systems and instrumentation, and completing cGMP documentation including corrective and/or preventive actions, change controls, deviations, qualifications/validations, and addressing of audit observations.  This position is also responsible for maintaining a safe work environment in compliance with CAL OSHA and other local, state, and federal regulatory agencies. 

Responsibilities

• Maintains and repairs control systems including networked automation, PLC, and DCS systems. 
• Designs and specifies automated controls systems. 
• Authors and/or reviews URS, FRS, SAT, I/O/PQ, CSV, and SOP documents. 
• Researches new technologies and makes recommendations for improvements and/or upgrades. 
• Documents changes to systems per change management procedures. 
• Supports activities for commercial readiness at Abzena. 
• Works autonomously and with minimal supervision. 
• Operates with ethical and moral standards in compliance with Abzena's policies and procedures. 
• Communicates effectively with clients, supervisors, colleagues, and staff. 
• Participates effectively as a team player in all aspects of Abzena's business. 
• Adheres to quality standards set by regulations and Abzena policies, procedures, and mission.  
• Performs other duties as assigned. 

Ancillary Job Functions (Other Duties May Be Assigned)

• Supports changes to validated and non-validated control systems to minimize downtime. 
• Troubleshoots using systematic approaches to determine root cause and prevent recurrence. 
• Participates in reliability programs, including trending, proactive risk analysis, and strengthening control system maintenance and technical training programs. 
• Ensures compliance in cGMP documentation. 
• Schedules installations, repairs, and maintenance with affected parties. 
• Authors requests, solicits technical quotations, and oversees contractors and vendors. 

Qualifications

• Bachelor's degree in Engineering, Computer Science, or related discipline. 
• 7+ yearsof direct experience withBiologics Manufacturing organizations. 
• Proven track record in cGMP manufacturing operations support, including problem solving and successful delivery of automation projects. 
• Advanced knowledge of controls networking protocols (e.g. Ethernet/IP, BACnet, DeviceNet, OPC UA, etc.)  
• Advanced knowledge of automated biologics manufacturing systems (e.g. Sartorius Biostat STR, Sartoirius AMBR, Cytiva AKTA Pure, etc.) 
• Advanced knowledge of SCADA and data historian systems (e.g. Sartorius Biobrain Supervise, Sartorius BioPAT MFCS, OSI Pi, etc.) 
• Strong controls background and expertise in biologics products for cGMP operations. 
• Ability to achieve results through teamwork and influence, streamlined execution, and innovation. 
• Leadership and communication skills. 
• Demonstrated ability to develop constructive and effective relationships with third-parties, colleagues, and Abzena management. 
• Demonstrated ability to effectively communicate across functions to meet management, customers, and client expectations. 
• Must travel between facilities to support all functional areas. 

FLSA: Exempt 
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.