Lead Process

il y a 3 semaines


Antwerp, Belgique fortil Temps plein

Job Responsibilities:

  • 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.
  • Prepare Tender package and participate in discussions for supplier decision.
  • Define the applicable standards/norms/engineering guidelines for the project
  • Provide suppliers with the applicable standards
  • Challenge technical solutions coming from suppliers
  • Integrate safety, sustainability and green assessment in the design
  • Define List of Deliverables for his/her discipline
  • Provide project deliverables of his/her discipline to Process Lead
  • Track supplier’s planning adherence for installation of systems. Progress report to be delivered to Process and technical lead
  • Organize quality checks on field before each technical milestone activity
  • Communicate the day to day schedule to the Process and Technical Leads
  • Ensure a good communication with other stakeholders linked to its activity (Battery limits)
  • Maintain his knowledge accuracy based on new technology. Keep up-to-date
  • Write the specifications related with its area of expertise and provide the document to the Process Lead for review
  • Define battery limit and RACI matrix with Process Lead
  • Update drawings in its area of expertise
  • Write commissioning documentation and ensure that the supplier's documentation is acceptable to perform verification (ASTM 2500)
  • Perform FAT/SAT activities in its area of expertise
  • Support the qualification phases after commissioning (V-Cycle and/or ASTM2500)
  • Organize the training of the final user in its area of expertise & provide technical documentation in to finalize the hand-over
  • Actively perform the tasks to an efficient Hand-over in its area of expertise, with the follow-up of the associated punchlist
  • Respect documentation strategy

Qualifications:

  • 10+ years of relevant 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.
  • 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.
Seniority Level

Associate

Employment Type

Full-time

Job Function

Engineering, Manufacturing, and Production

Industries

Pharmaceutical Manufacturing, Biotechnology Research, and Chemical Manufacturing

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