Lead Process
il y a 3 semaines
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.
Associate
Employment TypeFull-time
Job FunctionEngineering, Manufacturing, and Production
IndustriesPharmaceutical Manufacturing, Biotechnology Research, and Chemical Manufacturing
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