Global leader in the Biotechnology industry is seeking a professional Automation Engineer for employment. As a member of the Engineering and Facilities Reliability Automation team, the successful candidate will be required to support complex and challenging system automation initiatives that require solid understanding of analytical problem-solving techniques, project management, lifecycle management and Operational Excellence. This position requires an extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
Job Responsibilities include:
Day-to-day operational shift support for process control applications utilizing Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA). In-depth knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate must have experience in change control, quality deviations, corrective and preventative actions, and qualification practices. Lead technical root cause analysis, incident investigations, and troubleshooting of process control issues related to electrical, instrumentation and control systems for drug product and packaging systems.
Daily tasks completed in conjunction with the following product platforms.
- Rockwell Automation FactoryTalk & ControlLogix PLC Platforms.
- GE Intellution iFiX SCADA systems
- Wonderware SCADA systems
Day-to-day Operational Support
- 24 x 7 Onsite/On Call for Day to Day Operational Support
- Troubleshooting Support to Mfg. Operations
- Automation System Administration
- Data Integrity Assessments
- Automation System OS and HotFix assessments and rollout
- Automation Business Process Improvements
- Automation System Reliability & Life Cycle Management
- Daily Plant work center team meetings
- Preventative and corrective maintenance
- Automation System spare parts
- PPoF (Purposeful Presence on the Floor)
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). Lead and support of capital projects. This role involves the application of advanced automation engineering principles in the design, specification, construction, startup, and qualification of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles is preferred. Candidate should be familiar with engineering processes from initial conceptualization through project turnover to operations. 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 operating standards.
Ownership and administration of process control automation in a GMP regulated manufacturing setting. Engage in, and process change control requests per established SOP and processes. Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation and control systems. Design and testing of newly installed and currently installed automation-based process equipment. 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.
- S or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering.
- Strong control system automation background. Design, installation, programming and validation of automated processes is essential.
- Strongly preferred - 5 or more years combined experience with the following product platforms. Rockwell Automation FactoryTalk & ControlLogix PLC Platform. One or more years’ experience leading a team as well as work self-directed.
- Ability to create, update and read electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation.
- Knowledge of ASTM 2500, 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 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, Building Management System and Filling systems for Syringe and Vials
- 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, Depyrogenation oven, COPs and Glass Washers, Pressure Vessel Washer, Vial Washer and Ultrasonic Washer)
- 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.