Process Automation SME
- Belgium, Brussels
- Contract
- Life Sciences
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.
- 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!
#LI-CB1
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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