Sr. Automation Engineer
- 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 validation 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 functional specification, detailed specification, engineering documents, SOP and operating standards.
- Ownership and administration of process control automation in a pre-pivotal phase appropriate and/or cGMP 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.
- Master’s degree OR Bachelor’s degree & 2 years of directly related experience OR Associate’s degree & 6 years of directly related experience OR High school diploma / GED & 8 years of directly related experience.
- B.S or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering.
- Strong control system automation and bioprocessing background focused specifically in design, installation, programming and validation of automated processes are essential.
- 2 or more years combined experience with the following product platforms.
- a. Emerson DeltaV DCS systems version 12 or above.
- b. Rockwell Automation Factory Talk & ControlLogix PLC Platform is a plus.
- c. One or more years’ experience leading a team as well as work self-directed.
- Ability to create, update and read electrical and process design packages including URS, FS, SDS, ICO, ACO, IQ, OQ, CSR and VSR among other engineering and validation documentation.
- Knowledge of ASTM 2500, S88 and S95 industrial automation standards. Continuous batch processing is a desired advantage.
- Strong leadership, technical writing, and communication/presentation skills are required.
- Work schedule flexibility as required to support on-going process operations, requiring occasional after-hours engineering coverage as needed.
- Collaborate and support development of automation strategies for New Product Introduction and New Technology Deployment.
- Direct experience in process control engineering and troubleshooting with both stainless steel and single-use unit operations such as bioreactors, harvest, depth filtration, viral inactivation, chromatography, viral filtration, and ultrafiltration/diafiltration.
- Cleaning systems: CIP’s, COP’s, Glass washers, and Autoclaves.
- Position requires a working knowledge of manufacturing IT network, data historian, electronic batch records, OPC, Profibus, Ethernet IP, Modbus and DeviceNet technologies.
- Working knowledge and experience with pre-pivotal phase appropriate and/or 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.