Senior Process SME
- Belgium, Brussels
- Contract
- Life Sciences
We are looking for an experienced Senior Process 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:
- Large Experience with EPCMV (Engineering, Procurement and Construction Management & Validation) contracting models is mandatory.
- Ability to lead package in collaboration with suppliers from design to qualified status.
- Ability to lead & review PED (Pressure Equipment Directive) is a relevant asset
- Ability to act as technical process expert during HAZOP (Hazard and Operability study) / QRA (Quality Risk Analysis) / FMEA
- Knowledge in qualification & validation approaches (ASTM E2500) is highly important
- Good technical knowledge in bioprocess equipment (USP, DSP, media/buffer) and their applicability.
- Good knowledge in automated systems (Siemens PCS7) and understanding of IT security requirements (data integrity)
- Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is preferred.
- Experience in large and complex projects as well as both formal and informal leadership / coordination
- Capable to benchmark with peers in the industry and able to identify latest trends
- Excellent communication skills in order to present frequent reports to Management.
- Produce and Review the URS in order to ensure all User requirements are fully respected
- Include all technical requests in the URS for the commissioning and qualification.
- Extensive experience within pharmaceutical companies and working with Engineering offices
- Requires project management experience in pharma, knowledge of qualification, and equipment design.
- Experience: Preferably in CAPEX projects within a commercial GMP facility.
- Good Upstream and Downstream Process Technical expertise.
- Good knowledge in automated system.
- Good Knowledge of cGxP requirments.
- Automation: Siemens PCS7 knowledge beneficial; the role involves verifying compliance with software requirements.
- Languages: English mandatory; French highly desirable as French speaking Team.
#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
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
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
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