As a commissioning professional, you will be responsible for ensuring the smooth operation of new equipment in our aseptic manufacturing facilities.
Key Responsibilities:
* Commissioning and qualification of new aseptic manufacturing equipment
* Development and execution of qualification documentations such as FAT, SAT, IOQ, PQ protocols
* Support for the development of URS and Functional Specification associated with aseptic processing
* Technical assistance during investigations or process/equipment issues
* Ensure on-time execution of schedules and reports
* Periodic Review plans completion per site & regulatory requirements
* Collaboration with various departments/teams in validation activities associated with new equipment/product introductions and process improvements
* Validation activities management in conjunction with company and regulatory requirements (Health & Safety, cGMP, construction, environmental etc.)
* Change control assessments impact on validated state of process equipment
* Leading Risk assessments, root cause analysis and investigations as applicable
* SOP ownership and adherence to corporate standards and regulations
Equipment qualifications include Single Use Equipment, Mobile Equipment - SUM/TCU/Utility Panels/Reactor Facility Qualification OR Fine Line (Vial / Syringe ) / Lyo /Capper / External Vial Washer
About Our Team:
We partner with leading life science and technology companies to deliver strategic projects with technically strong personnel ensuring all important activities meet current requirements and client needs.