We are looking for an IT automation engineer for a 1-year contract with our client, a global pharmaceutical company in the Neuchatel area,
Prerequisites
Expertise in Industrial IT and Automation on GxP Systems in a Pharmaceutical environment
Proficiency in Equipment Qualification and Computer System Validation
Autonomous, driving projects from architecture to decommission
Strong relationship and collaboration skills (verbal and written)
Responsibilities
Work closely with various automation, IT, Manufacturing and QA stakeholders to execute the daily operational activities and maintain the systems in a compliant state.
Implement corrective actions as defined by the Deviation management or the Change Control Process that can include (but not limited to) automation code changes, review, design document updates & re-approval, SOP updates and training.
Manage Commissioning & Qualification activities (SAT, IQ, OQ) for the 2022 defined projects related to automation systems
Work independently and supervise the activities of suppliers
Contribute positively to a strong culture of business integrity and ethics
Act within compliance and legal requirements as well as within company guidelines
Skills/Knowledge Requirements
Engineering educational background preferably in Automation, Bio or Chemical processing
Minimum 2 years of experience in a pharmaceutical/biotech environment with automation systems
Demonstrated hands-on experience with automation systems
Good Knowledge of specific manufacturing systems (Serialization software, building management Systems, Room Monitoring systems, etc.)
Good knowledge of Pharma/Biotech Processes, Utilities and HVAC equipment
Awareness of Industry 4.0 and related topics.
Good knowledge of IEC 61131, ISA-88 and ISA-95 Standards
Good knowledge of SCADA software and PLC (Siemens, Allen-Bradley, etc.)
Knowledge of other platforms is an advantage
Good knowledge of Computer Networking and Fieldbus.
Design, configuration, installation, and maintenance of automation software and
associated hardware.
Oversight or participation in all automation aspects of the overall automation projects lifecycle (URS, FS, DS, SDS, FAT, SAT, IQ, OQ, PQ and system support as well)
Develop procedures and maintain proper documentation related to automation systems
Troubleshooting skills to recover system critical functionalities
Understanding of electrical and P&ID standards
Awareness of 21-CFR Part 11, Eudralex, MHRA
Familiar with GMAO software and IT Ticketing systems (ServiceNow)
Awareness of business and enterprise architecture
Analyse, interpret data, and make sound technical recommendations on continuous improvements and non-conformance remediation
Good knowledge GxP/GAMP/Data Integrity practices
Ability to handle multiple projects in parallel
Excellent analytical and report writing skills
Excellent presentation, facilitation, negotiation, collaboration, and communication abilities
Capable of working under pressure in a multi-cultural environment, at any level of the hierarchy, effectively with a variety of stakeholders
Fluent in French and English
***This position has now been filled, please contact recruitment@consultantsinscience.com to be informed of future similar positions***
Bình luận