The Biologics organization seeks a Senior Automation Engineer to lead the implementation of a standardized Automation Recipe Lifecycle approach from new growth assets into operation.
This is an opportunity to collaborate with Automation and Operations across all of the Biologics Manufacturing Assets to coordinate recipe object updates, testing, documentation, and installation.
Key Responsibilities:
* Support implementation of a standardized recipe lifecycle approach for products already in the routine manufacturing phase
* Drive development of recipes for major growth projects
* Author cGMP-compliant documentation (FS, Software Test Cases, SOPs, etc.) in collaboration with the Bioprocess engineer, Plant Lead, QA, and MSAT
* Supervise and change processes under change control during the start-up, qualification and production phase. Participate in risk and process deviation analyses
* Provide support outside of normal working hours (in outstanding cases such as imminent production downtime, security, etc.)
* Build and modify shared recipe objects, and define EC Modules in the MES / DeltaV systems to run production processes
* Improve procedures and processes in compliance with the safety, hygiene, environmental and quality requirements in the area of responsibility
The ideal candidate will have a degree in Biotechnology, Biochemistry or related fields, and structured work ethic. Solution-orientated and open-minded for new insights are also required.
Requirements:
* Degree in Biotechnology, Biochemistry or related fields or equivalent experience
* Structured, focused and well organized work ethic. Solution-orientated and open-minded for new insights
* Expertise with MES Syncade and DeltaV is highly desired and familiarity with other GMP systems (LIMS, SAP, MODA, etc.)
* Ability to recognize risks in relation to security or compliance / GMP, discusses them and helps resolve them
* Outstanding team and communication skills
* Very good understanding of IT / process control systems. Recognizes operational optimization potential
* Independently implements the measures assigned to optimize security, costs or operational processes
In this role, you will have the opportunity to make a meaningful difference in people's lives by improving the production process.