Our customer is a big international pharmaceutical company.
Ensure in-house "expert" role in the field of his discipline and beyond.
Support the clean utilities engineer of the engineering contractor : provide expertise, guidance and direction on all aspects of his discipline. Overview and support the engineering company in their day to day activities for the development of technical solution compliant with cGMP criteria, user needs and allocated budgets. Find the correct balance between compliance to standards, to quality and to business needs (including cost effectiveness).
Act as a key interlocutor of the project team to internal stakeholders (QA, Global Engineering).
Be the project team’s single point of contact (SPOC) from and to the engineering contractor.
Overview the writing of technical specifications, participate in supplier selection with procurement, compare strategic technical bids.
Participate to budget forecast.
Support the project management: guarantee the timing and respect of allocated budget.
Project Execution (2019):
Drives the engineering contractor and/or contractor for the design, execution and startup of projects in his discipline in quality, planning and cost.
Support necessary decisions at supplier location to ensure proper project execution.
Participation to FAT
Overview construction activities
Overview of commissioning, IQ, OQ
Support to manufacturing teams in charge of doing PQ
Overview and follow-up the activities performed by the selected engineering contractor for the delivery of equipments / systems in the following technologies :
- Washing Machines
- CIP/COP stations
- Sterilization and decontamination equipment’s
- Clean utilities generators
- Clean utilities distributions
The role needs the expertise in delivering validated equipment’s and systems compliant to the customer needs and specification.