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Senior Process SME

  1. Belgium, Brussels
Brussels
  1. Contract
Competitive
  1. Life Sciences
36237
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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!
 #LI-CB1

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