Senior Process SME - Brussels, Belgium - 23 Months Contract
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
- Process: Good technical knowledge in bioprocess equipment (USP, DSP, media/buffer) and their applicability.
- Digital: Good knowledge in automated systems (Siemens PCS7) and understanding of IT security requirements (data integrity)
- Quality: 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.
Requirements:
- Extensive experience in large scale EPCMV Projects in the pharmaceutical industry
- In-depth technical experience in a regulated environment with knowledge of gene therapy, biologicals, pharmaceutical and engineering operations
- Good Expertise in automated systems within the large-scale pharmaceutical industry
- Leading the Process & Automation team
- Large experience in basic/detailed design, equipment installation and commissioning
- Driving consistency within Engineering standards, norms and regulations
- Supporting qualification and validation activities
- Ensuring adherence to EHS regulation and Green good practices.
- Good Upstream and Downstream Process Technical expertise
- Good Knowledge of cGxP requirements
If this role is of interest to you, please apply now!
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