Job Title: Automation Engineer
We are seeking an experienced Automation Engineer with a background ranging from 2 to 8 years in one or more major platform technologies listed in the skills section of this job description. The successful candidate will have hands-on experience in all phases of project delivery, including FEED Study, Conceptual Design, Basic Design, Detailed Design, implementation, testing, CQV, as well as ongoing support for GMP facilities.
The candidate should be proficient in developing comprehensive Lifecycle documentation for GMP-regulated facilities, collaborating closely with client user teams, process teams, and automation teams. The role requires experience with bioprocessing operations and equipment, including prep tanks, bioreactors, fermentation systems, harvest, and purification processes.
Responsibilities:
- Self-manage the design, implementation, and testing of automation system graphics, I/O databases, control modules, interlocks, alarms, sequences, and recipes, ensuring all associated life-cycle documentation is developed and controlled.
- Develop configuration standards for the execution of automation system projects.
- Manage GMP documentation, including URS, FS, DS, RTM, IQ, and OQ, throughout projects, including creating, redlining, approval, and management in various document control repositories.
- Interpret P&IDs, electrical drawings, and control narratives; redline/markup P&IDs and electrical drawings on the production floor or in automation panels.
- Configure and test batch code, including units, phases, operations, unit procedures, procedures, and recipes with exception logic.
- Apply industry standards such as GAMP 6, 21 CFR Part 11, ISA S88 & S95 effectively.
- Conduct regulated testing, including IQ & OQ, and leverage FAT and SAT to enhance IQ & OQ efficiency.
- Support onsite ongoing operations, including Make, Assess, Release, and change control processes.
- Handle CAPAs (Corrective and Preventive Actions), including investigation, documentation, root cause assessment, and proposing 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, CIP and SIP.
- Knowledge of critical utilities, including clean steam, WFI, purified water, compressed air, and nitrogen gas.
Skills:
- Emerson DeltaV
- Rockwell PLC family, PanelView family, FactoryTalk View SE
- Siemens SIMATIC S7, SIMATIC PCS 7, SIMATIC HMI family
- ABB DCS 800xA
- AVEVA
- Honeywell Experion
- DeviceNet, Foundation Fieldbus, Profibus, Modbus, HART, Ethernet I/P
Abilities:
- Communicate clearly and effectively with internal team members and external customers.
- Identify and solve problems promptly and efficiently.
- Focus on, complete, and prioritize assigned tasks on time.
- Collaborate and work effectively with others, respecting diverse opinions and building trust towards a common goal.
- Act with integrity, professionalism, and confidentiality.
- Create and maintain a positive attitude.
- Remain calm under pressure and demonstrate flexibility in problem-solving.
Qualifications/Experience:
- Bachelor of Science degree in Engineering (Chemical, Electrical, Mechanical, or Computer Science).
- Master of Science degree preferred.
- Strong understanding of cGMP validation requirements and current industry practices.
Apply online using the form below. Only applications matching the job profile will be considered.