Job Title: Sr. Engineer (PLC/SCADA)
Location: Thousand Oaks, CA 91320
Duration: 3 Years
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
Top 3 Must Have Skill Sets:
- 5+ years of experience working on Rockwell Automation and Allen-Bradley PLCs (Factory Talk & ControlLogix)
- Experience with Process Design, Commissioning and change control methodology.
- Direct experience with regulated environments including detailed understanding of cGMPs.
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 Rockwell 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:
- a. Lyophilizer System, Filling systems for Syringe and Vials and Building Management System
- b. Testing and Inspection machines for devices
- c. Clean Utilities (WFI Still A\B, Clean Steam Generator, Chemical Dist. System, WFI Storage & Distribution and Purification System)
- d. 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.