In this role, you will provide insight on testing frequency & sampling locations to improve effectiveness of the environmental monitoring program based on knowledge and significant direct observation in the operating environment.
In this role, the selected candidate will be responsible for performing validation of equipment, utility systems, facilities, processes and/or automation systems by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
The ideal candidate will collaborate with key stakeholders and the Technical Validation team to help define needs and achievable solutions and/or justifications for equipment requirements and related validation.
Develop qualification and validation protocols for manufacturing systems and equipment such as ultra filtration units, chromatography columns, automation controls, utilities, clean rooms, temperature controlled areas, pasteurizers, lyopholizers, etc.
The CIP Validation that will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing and maintaining the CIP validation program in a GMP environment.