Process Automation SME - Brussels, Belgium - 23 Months Contract
We are looking for an experienced Process Automation SME for a fantastic 23 months contract based in Brussels, Belgium.
You will be working with our client who are a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease.
This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first.
Responsibilities:
- Understand and translate Automation functional specification to process SME to ensure requirements are fully answered.
- Strong background within manufacturing M&B(Media and Buffer) or USP or DSP process equipment
- Ability to interpret and set-up P&ID (Piping & Instrumentation Diagrams) and PFD (Process Flow Diagrams) is required.
- Knowledge in qualification & validation approaches (specially ASTM E2500) is highly relevant
- Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is required.
- Ensure technical requirements are met within automation design provided by suppliers.
- Include all technical requests in the URS for the commissioning and qualification.
- Ensure for its Packages that deliverables will be provided timely and aligned with project planning with the right expected quality and according to the allocated budget.
- Report the progress for its Packages.
- Be accountable for its Packages and in strong collaboration with Automation Integrator company.
- Align design expectations with the other project disciplines: Process, QA Q/V, Utilities, E&I, etc.
- Anticipate, manage and report risks from Detail Design till validation batches.
- Perform Design review and Design Verification with the Engineering office and the CQV team
- Lead and Participate to the FAT/SAT of Equipment in the scope
- Support the qualification phases after commissioning (ASTM2500)
- Organise quality checks on field before each technical milestone activity.
- Ensure a good communication with other Specialists linked to its activity (Battery limits)
- Maintain his knowledge accuracy based on new technology. Keep up-to-date.
Requirements:
- Extensive experience in in the pharmaceutical industry projects.
- Masters Degree in Engineering/Automation
- Expertise in Automation for Biological processes
- In-depth technical experience in a regulated environment with knowledge of biologicals, pharmaceutical and engineering operations
- Expertise in DCS system and preferably PCS7 (with Batch)
- Large experience in detailed design, equipment installation and commissioning
- Supporting qualification and validation activities
- Good understanding of EHS (Environment, Health and Safety) and Quality aspects
If this role is of interest to you, please apply now!
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