Job Description
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 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.
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.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training
