The 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.
Qualifications- Bachelor of Science degree in STEM field or relevant leadership experience. In depth working knowledge of cGMP requirements.
- Five (5) years systems administrator / IT/ automation experience with three (3) years in pharma / biotech industry.
- Demonstrated track record in:
- Proven track record in cGMP manufacturing operations support, including problem solving and successful delivery of assigned projects.
- Knowledge of controls networking protocols (e.g. Ethernet/IP, BACnet, DeviceNet, OPC UA, etc.).
- Knowledge of automated biologics manufacturing systems (e.g. Sartorius Biostat STR, Sartoirius AMBR, Cytiva AKTA Pure, etc.).
- Knowledge of SCADA and data historian systems (e.g. Sartorius Biobrain Supervise, Sartorius BioPAT MFCS, OSI Pi, etc.).
- Controls background in biologics products for cGMP operations.
- Ability to achieve results through teamwork and influence, streamlined execution, and innovation.
- Familiarity with regulations including 21 CFR Part 11, GMP, and GxP.
- 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.
$100,000 - $140,000 a year
FLSA: Exempt
