Global leader in the Biotechnology industry is seeking a professional Automation Engineer for employment. As a member of the Advanced Technology and Automation (ATA) Team, the successful candidate will be required to support complex and challenging system automation initiatives that require solid understanding of analytical problem-solving techniques, process and operational support, lifecycle management and Operational Excellence. This position requires an extensive understanding and background in programming, configuration, and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
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 of capital projects. This role involves the application of advanced automation engineering principles in the design, specification, configuration, startup, and commissioning 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 regulated manufacturing setting. Engage in, and execute managed process change requests per established SOP and processes.
- Gather data and participate in 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.
- Apply standard process control methods and approaches to complex problem solving.
- Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
- Masters degree OR
- Bachelors degree & 2 years of directly related experience OR
- Associates 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 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: Emerson DeltaV DCS systems version 11 or above, Rockwell Automation Factory Talk & ControlLogix PLC Platform, Siemens TIA Portal
- Ability to create, update and read electrical design packages including URS, FS, SDS, HDS, IQ, OQ 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 and weekend engineering coverage.
- Experience in developing and implementing automation strategies for New Product Introduction and New Technology Deployment.
- Direct experience in process control engineering and troubleshooting with unit operations such as media, harvest, bioreactors, chromatography, vial filtration, and ultrafiltration/diafiltration. Any experience with continuous batch processing will be preferable.
- Experience utilizing the PI data historian.
- Cleaning systems: CIPs, COPs, Glass washers, and Autoclaves.
- Position requires a working knowledge of building automation systems, electronic batch records, PLC, OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies, as well as HVAC, purified water systems (RO, WFI).
- Working knowledge and experience with change management procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment.
- 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.
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Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.