Process Automation SME
- Brussels
- Contract
- CAPEX Projects
This vacancy has now expired
We are looking for an experienced process automation SME for a fantastic 6-month contract based in Brussels.
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:
- Lead the Automation topics in process scope
- Understand and translate Automation functional specification to process SME to ensure URS&TRS requirements are fully answered.
- Strong background within manufacturing M&B(Media and Buffer) or USP or DSP process equipment’s
- Ability to interpret and set-up P&ID (Piping & Instrumentation Diagrams) and PFD (Process Flow Diagrams) is required, as well as mass balances.
- 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 preferred.
- Review the URS provided by the Engineering Office in order to ensure all User requirements are fully respected
- Include all technical requests in the URS for the commissioning and qualification.
- Review and participate in the technical specs and datasheets from Engineering Office
- Review Functional specification for Automation from Engineering Office
Requirements:
- Masters Degree
- 15+ Years experience working on large scale pharmaceutical projects
- Strong Knowledge of PCS7 within Automation
- Strong knowledge of GxP requirements
- Ability to manage key stakeholders (Engineering Office, User and Others)
- Expertise in Automation for Biological processes
- In-depth technical experience in a regulated environment with knowledge of gene therapy, biologicals, pharmaceutical and engineering operations
- Expertise in single use systems within the pharmaceutical industry
- 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
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
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
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Chris
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