Process Automation Engineer

Client: Biotech

Job Title: Automation Engineer

Duration: 36 Months

Location: Thousand Oaks, CA 91320

Schedule: Fully Onsite; 8am-5pm M-F

Pay : $70-75/hr.

Job Responsibilities include:

• Developing process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).


• Support projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug product manufacturing technologies into clinical/commercial facility.


• Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.


• Development of detailed specification, engineering documents, SOP and computerized system administration job plans. Testing of automation-based process equipment.


• Ownership and administration of process control automation in a GMP regulated manufacturing setting. Engage in process change control requests per established SOP and processes.


• Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to mechanical, electrical, instrumentation and control systems.


• Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.


• Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.


• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations

Basic Qualifications:

• Doctorate degree OR - Master s degree & 2 years of directly related experience OR - Bachelor s degree & 4 years of directly related experience OR - Associate s degree & 8 years of directly related experience OR High school diploma / GED & 10 years of directly related experience.

Preferred Qualifications:

• B.S or M.S. in Electrical Engineering, Chemical Engineering, Mechanical Engineering, or Biotech Engineering.


• Strong control system automation background focused specifically in design, installation, programming and validation of automated processes are essential.


• 5 or more years combined experience with Automation Factory Talk & ControlLogix PLC Platform.


• Ability to create, update and read electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation.


• Knowledge of S88 and S95 techniques. - Batch processing a desired advantage.


• Strong leadership, technical writing, and communication/presentation skills are required.


• Work schedule flexibility as required to support 24/7 operations, requiring daily on-site and occasional after-hours engineering coverage.


• Experience in developing automation strategies for New Product Introduction and New Technology Deployment.


• Preferred Experience using the following systems:


• Lyophilizer System, Filling systems for Syringe and Vials and Building Management System


• Testing and Inspection machines for devices


• Clean Utilities (WFI Still A\B, Clean Steam Generator, Chemical Dist. System, WFI Storage &


• Distribution and Purification System)


• Cleaning Systems (Autoclaves, Depyro oven , COPs and Glass Washers, Pressure Vessel


• Washer, Vial Washer and Ultrasonic Washer)


• Position requires a working knowledge of building automation systems, electronic batch


• records, PLC, OPC, Profibus, Ethernet/IP and DeviceNet technologies.


• Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, nonconformance, corrective and preventative actions, and validation practices.


• Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Individual must be a team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.