CQV Engineer - GMP Warehouse (Contingent Worker)
* Employment type: Contingent worker, under third party
* Contract duration: 12 months (possible extension or redeployment upon completion)
Description:
Lonza is currently looking for a CQV Engineer to meet the needs for the High Bay GMP Warehouse at the site in Stein (AG). The CQV Engineer will drive the execution and coordination of the defined CQ activities in the warehouse for both cold and ambient temperatures and support building.
Key Responsibilities:
* Ensure that CQV activities are executed in accordance with company guidelines, the C&Q Plan and supporting Validation Plans.
* C&Q SME for High Bay warehouse scope - cold and ambient (high preference).
* Support C&Q execution for key main equipment: Semiautomated and fully automated visual inspection machine, other small support equipment in the building (LAF, thawing units, fridges, freezers, cold/freezer rooms, etc.), including alignment with execution approach of equivalent systems in QC building.
* Execution of the commissioning activities related to allocated areas or systems.
* Coordination of execution activities with supporting CSV Team and global IT teams.
* Lead C&Q testing activities supported by vendors and contractors.
* Develop any supporting validation plans related to scope of execution.
* Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle.
* Interface with other disciplines: EHS, Automation, Electrical, Instrumentation, Operation and Engineering, etc.
* Assist the C&Q Lead with the Handover and Release process.
Key Requirements:
* A relevant Third Level or Professional Qualification.
* Ability to work well under pressure and within strict deadlines.
* Minimum of 8 Years extensive experience in areas/systems under future responsibility.
* Preferably Diploma level degree in Mechanical or Chemical Engineering.
* Previous experience in authoring CQV lifecycle documents necessary.
* Previous experience in qualifying a High bay warehouse (ambient and 2 to 8 degree cold room) necessary.
* Proactive and able to work independently.
* Considerable experience with cGMP.
* Strong interpersonal and communication skills.
* Fluent English (C1 Level), German an advantage.
* Experience in use of Kneat for documentation development and execution.
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Quality Assurance and Engineering
Industries
* Pharmaceutical Manufacturing
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