Clean Utilities and Environmental Devices Specialist
The role involves implementing commissioning and qualification of new/modified clean utilities and non GMP utilities and controlled environmental devices sitewide, ensuring systems and equipment are installed, commissioned and qualified to regulatory specifications.
Responsibilities:
* Develop documentation for commissioning/qualification of systems and equipment, including protocols and reports.
* Raise and implement system change controls.
* Participate in design reviews for new/modfied utility systems.
* Participate in construction system mechanical completion walkdowns.
* Perform execution of protocols and temperature mapping of equipment.
* Verify pre and post study calibration.
* Operate according to SOPs developed for validation, manufacturing operations and cGMP compliance.
* Develop and implement changes required to resolve deviations effectively.
Requirements:
* Bachelor's degree in engineering discipline, with particular emphasis on mechanical or process engineering.
* Minimum of 3-5 years' experience from biotechnology or pharmaceutical GMP manufacturing environment.
* Experience in temperature mapping and qualification of clean utilities/HVAC is an advantage.
* Demonstrated ability to work on own initiative and respond to business needs.
* Excellent interpersonal and communication skills.