Job Title: Automation Engineer
We are seeking a talented Automation Engineer with 2 to 8 years of experience and a high level of proficiency in one or more major platform technologies outlined in our skills section. This role involves extensive experience across all phases of project delivery, including FEED Study, Conceptual Design, Basic Design, Detailed Design, Implementation, Testing, CQV, and ongoing support for GMP facilities.
The ideal candidate will have hands-on experience with various bioprocessing operations and equipment, such as prep tanks, bioreactors, fermentation systems, harvest, purification (chromatography & UF/DF skids), fillers, isolators, CIP, and SIP.
Responsibilities
- Self-manage the design, implementation, and testing of automation system graphics, I/O databases, control modules, interlocks, alarms, sequences, and recipes while developing and controlling all associated lifecycle documentation.
- Develop configuration standards for automation system project execution.
- Manage GMP documentation, including URS, FS, DS, RTM, IQ, and OQ throughout projects, including creation, redlining, approval, and management in various document control repositories.
- Interpret P&IDs, electrical drawings, and control narratives and perform redlining/markup of P&IDs and electrical drawings on the production floor or in automation panels.
- Configure and test batch code, including units, phases, operations, unit procedures, and recipes, incorporating exception logic.
- Apply industry standards such as GAMP 6, 21 CFR Part 11, ISA S88 & S95 effectively.
- Execute regulated testing, including IQ & OQ, while leveraging FAT and SAT to reduce IQ & OQ testing scope.
- Support ongoing onsite operations through Make, Assess, Release, and change control processes.
- Manage CAPAs (Corrective and Preventive Actions), including investigation, documentation, assessing root causes, and delivering practical solutions.
Knowledge
- Familiarity with bioprocessing equipment and operations, including media prep, bioreactors, fermenters, harvest equipment, buffer prep, chromatography skids, filtration skids, fillers, isolators, and packaging.
- Understanding of cleaning operations, including CIP and SIP.
- Knowledge of critical utilities, including clean steam, WFI, purified water, compressed air, and nitrogen gas.
Skills
- Emerson DeltaV
- Rockwell PLCs, PanelView, and FactoryTalk View SE
- Siemens SIMATIC S7, SIMATIC PCS 7, and SIMATIC HMI family
- ABB DCS 800xA
- AVEVA
- Honeywell Experion
- DeviceNet, Foundation Fieldbus, Profibus, Modbus, HART, Ethernet I/P
Abilities
- Communicate clearly and effectively with both internal team members and external customers.
- Identify and solve problems promptly and efficiently.
- Focus on, complete, and prioritize assigned tasks on time.
- Collaborate effectively with others, respecting diverse opinions, building trust, and working towards common goals.
- Act with integrity, professionalism, and confidentiality.
- Foster and maintain a positive attitude.
- Remain calm under pressure, remaining flexible, open, and problem-solving oriented.
Qualifications/Experience
- Bachelor of Science degree in Engineering (Chemical, Electrical, Mechanical, or Computer Science) is required.
- Master of Science degree is preferred.
- Strong understanding of cGMP validation requirements/guidelines and current industry practices.
Apply online using the form below. Please note that only applications matching the job profile will be considered.