EPM Scientific is currently partnering with a client of the biotechnology industry - expanding in the german market building a drug substance manufacturing site.
KEY ACCOUNTIBILITIES:
* A key technical member of Automation and Integrated Service (AIS) global committee. Locally report to DP7 Site Engineering Head.
* As subject matter expert in automation and instrumentation to support drug substance (DS) automation platform, PCS system, and PLC based vendor package unit.
* Lead or assist automation project from URS to commissioning and qualification; own maintenance program to ensure system's valid status
* Perform activities such as account management, data backup, system configuration per MBR, troubleshooting and non-compliance investigation
* Prepare /maintain/update necessary documentation, SOP, report for all stage GMP activities
* Prepare and support internal /external audit
* Conduct system health monitoring, opportunity assessment and continuous improvements
* Work closely with production and quality team to provide day-to-day support to manufacturing such as data retrieving, printing reports, alarm response and escalation
* Key vendor management to ensure high quality service is provided timely and efficiently
REQUIREMENTS:
* Bachelor's degree in Electrical, Computer or Chemical Engineering
* Prior experience of working in biologics /chemical process and manufacturing automation support, maintenance, and project management
* Familiar with GMP Guidelines
OTHER SKILLS, ABILITIES & EXPERIENCE:
* Excellent oral and written communication skills
* Ability to work collaboratively within team and with other departments
* Ability to work effectively with minimal supervision
* Has CAN DO attitude to meet new challenge
If you interested in this opportunity - reach out for more Information!
