Process SME - Belgium - 10 Months Initially - €564 per day
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My Client a Leading Pharmaceutical Company based in Belgium requires a Process SME
Summary of the Function
The mission of the Process Subject Matter Expert (for its group of packages / process module):
Takes the role of SME (technical reference) for defined process packages / modules
Writes, reviews, approves the technical documentation required to support the project
Actively participates in supplier monitoring (technical, planning, change management)
Support the Process Lead in the management of the relationship with suppliers and Exyte.
Ensures that all interfaces with its packages / process modules are correctly defined.
Actively participates or supports activities as needed or requested.
Main Tasks
The main tasks of the SME Process are:
Actively participate in the definition and implementation of technical activities by the equipment suppliers. Control the progress of these activities in connection with the defined schedule.
Identify the risks during the execution of the package (HSE, quality, cost, timing, change ...), estimate their impacts and report them to the Process Lead.
Actively participate in the definition and realization of interfaces with the EC so that the equipment can be integrated effectively and efficiently.
Coordinate effectively and efficiently between the different functions of the project and their SMEs (Clean Utilities, Infrastructure, C&V, Automation, etc.) and the EC.
Check that the DOMs are complete (decisions and actions). Follow up on actions according to the set deadlines.
Write, review and approve the technical documents required by each phase of the project, applying GEP, GMP, standards.
Ensure that Process equipment is developed in a harmonized manner, according to industrial technical standards and by applying GEP and GMP rules.
Implement the defined C&V strategy. Establish and / or review the documentation required for FAT / SAT / Commissioning / Verification.
Participate in the preparation and planning of each stage of the project (Design, Purchase, FAT, MC, SAT and HO). Carry out the activities required during these different phases.
Check your training plan and make sure it is up to date.
Participate in the integration of newcomers to the project by coaching them as needed.
Level of studies
Bachelor's Degree
Master's Degree
Ph.D.
Law (J.D.)
Medical Degree (M.D.)
Other (Specify):
Experience
Experience in pharma / biotechnology production in a GMP environment
Experience in qualification / validation of equipment
Good knowledge of automated systems
Skills
Experience in biotech or pharma production
Experience in the design and operation of biotech / pharma production equipment for monoclonal antibody purification processes
Experience in the design and commissioning of CIP stations
Experience in C&V with application of ASTM E2500
Strong knowledge of GMP and regulations
Demonstrate a very good team spirit
Know how to be autonomous and pro-active
Know how to take initiatives
Ability to positively challenge and argue
Decision-making and responsibility at its level
Able to work in a dynamic environment
Dealing with urgent situations
Description:
7 - 8 years of experience.
Master the CIP system.
Knowledge of English and French.
"Biotech manufacturing experience"
Production monitoring (DSP / USP)
Validation and monitoring of production line cleaning.
Deviation management in biotechnology production area
Implementation of new equipment for USP / DSP Revamping zone drug substance manufacturing.