Sr. Automation Controls Engineer at Avid Bioservices, Inc. in Tustin, CA

Avid Bioservices Inc., located in Tustin CA, is a dedicated contract development and manufacturing organization ("CDMO") focused on development and CGMP manufacturing of biopharmaceuticals products derived from mammalian cell culture. Avid provides a comprehensive range of process development, high quality CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 28 years of experience producing monoclonal antibodies, enzymes, and recombinant proteins in batch, fed-batch, and perfusion modes, Avid's services include CGMP clinical and commercial product manufacturing, purification, release and stability testing as well as regulatory strategy, submission and support. Avid also provides a variety of process development activities, including cell culture and feed optimization, analytical methods development, and product characterization.

We are dedicated to the improvement of global patient outcomes by delivering world-class services. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch. Do you possess the skills and expertise below to improve patient lives and support patient innovative therapies? If so, apply today!

Summary/Objective:

The Sr. Automation Controls Engineer maintains control systems for manufacturing processes and utilities in a maximum state of reliability. Identifies problems and potential issues with control systems and automated processes. Participate in plans, installs, start-up, commissioning, document upgrades/installs of PLC, DDC, DCS, SCADA based control systems for Biopharmaceutical process equipment and Plant Utilities. Serve as a lead in all technical requirements for the facility equipment especially the bioreactors (stainless steel and disposable STR/SUB) in order to ensure that the technical operations are aligned with maximizing production effectiveness and optimizing performance to lower overall operating costs. Partner with operations, quality assurance and any vendors and suppliers in order to create positive relationships to strengthen this proactive role in the facility.

Essential Duties and Responsibilities include the following; other duties may be assigned:

• Maintain existing control systems in reliable condition, propose improvements, and train/support manufacturing and maintenance personnel.
• Perform predictive, preventative and corrective maintenance efforts required to ensure efficient, reliable and uninterrupted plant operations.
• Automation program management (BAS, EMS, PLC, PAC, DDC, DCS & HMI). Maintain & Develop Automation Systems (Delta Controls, Delta V, REES, Wonderware, Sartorius, Allen Bradley, Maple Systems, & IDEC)
• Troubleshoot different controller software and hardware components.
• Oversee PID controls tuner and cascading controls (HVAC & Bioreactors).
• Industrial networking (DeviceNet, Modbus, Industrial Ethernet, BACnet etc.)
• Conduct timely/competent root cause analyses. Recommend/implement innovative, efficient and effective corrective actions resulting in stable and capable processes.
• Track and evaluate critical process data to recommend continuous process improvement.
• Develop and maintain electrical P&ID drawings.
• Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.
• Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.
• Support validation and manufacturing projects.
• Strict adherence to procedures and practices according to FDA regulations.
• Strong emphasis on documentation according to FDA standards.
• Adhere to departmental corporate safety policies.
• Maintain current knowledge of regulatory and industry standards.

Education and Experience

• Bachelor Degree in Electrical Engineering, Automation Technology or closely related technical discipline or comprehensive work experience.
• Minimum of 5-7 years experience in an FDA / cGMP regulated environment.
• Knowledge of engineering principles, design theory, maintenance systems, wastewater procedures, process methodology, sanitation practices, regulatory standards, energy systems and design.
• Project Management and Capital Projects experience.
• Experience managing multiple projects from the evaluation through implementation stages.
• Awareness of local and national codes and standards including NEC, UL, IEEE, NEMA, and OSHA.
• Experience with OSHA, Cal-OSHA Standards and Safety methods.
• Familiar with Windows Server, and VMware.