Principal Automation Engineer
About The Position
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent’s Advanced Therapeutics Division is a contract development and manufacturing organization providing products and services for our clients that provide medicines for many indications improving health for patients. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com. Join a growing team with this exciting new opportunity for a Principal Automation Engineer in our Automation group supporting design, construction, and operation of pharmaceutical facilities. Work in our dynamic, fast paced, API-Biopharma manufacturing environment with the ability to contribute to the growing industry of oligonucleotide (DNA-RNA) based therapeutics.
Requirements
- Bachelor’s / Master’s degree or equivalent. Postgraduate, certification, and/or license may be required.
- 10+ years relevant experience for this leadership position.
- Demonstrated communication skills, including verbal and written communication, in contact with vendors, internal customers, and employees.
- Knowledge of Good Manufacturing Practices (GMP), good automation manufacturing processes (GAMP), and Good Documentation Practices (GDP).
- Knowledge of data integrity and 21CFR11 requirements and for the design qualification of Biotech/pharmaceutical GMP computerized systems
- Knowledge of computerized systems’ server and personal computer hardware, networking, operating systems, integrated architecture, cyber security and resiliency.
- Knowledge of automation standards including ISA-88 (S88), ISA/IEC 62443,ISA-95, and ISA-101.
- Knowledge of OSHA, local safety guidelines, lock-out tag-out, and hot work permits.
Nice To Haves
- Utilize leadership skills to manage staff and contractors
- Exposure to CSV/MES/DCS/PCS/SCADA/PLC/LIMS/EBR/QMS/PDH
- Tools: Agile PLM, MS Project/Smartsheet, RAM CMMS, TMS DCS
- Demonstrate the Agilent core values of integrity, trust, respect, teamwork, accountability, focus, innovation, and speaking up.
- Experience with supervision of personnel / coordination of group work activities.
- Experience in a highly regulated industry with strict documentation requirements
Responsibilities
- Function as Automation Project Lead for a large-scale greenfield manufacturing expansion
- Evaluate and recommend the preferred automation integration platform for a new facility.
- Establish automation requirements for site process control, independent bioprocessing skids, and building management systems.
- Establish requirements for plant data historian system
- Establish requirements for IT/OT infrastructure and system integration
- Evaluate distributed control system (DCS) and plant control systems (PCS) to define best platform for new production facility based on site location and functionality
- Develop Manufacturing Execution System (MES) platform and integration requirements.
- Coordinate MES and process data collection for Electronic Batch Records (EBR) implementation.
- Support of industrial control systems.
- Manage contract resources for Automation Integration, plant data historian integration, and Manufacturing Execution Systems integration
- Support Commissioning, Qualification, Validation (CQV) activities and function as primary point of contact on automation projects for CQV
Benefits
- eligibility for bonus, stock and benefits
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Principal
