Senior Expert, Engineering (Equipment & System Validation)

12,000. The number of associates worldwide working together to reimagine medicine! <br><br>The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.<br><br>The Senior Expert, Engineering will be responsible for ensuring compliance to the regulatory requirements of the facilities, utilities, equipment and analytical instruments qualification processes and activities performed in the Novartis, Cell and Gene Therapy East Hanover, NJ facility. Recommends and implements improvements of the qualification process. Performs a variety of routine and non-routine tasks related to facilities, utilities, equipment and analytical instruments qualification, as managing and overlooking qualification projects and changes. Prepares risk and impact assessments and other evaluations. Supports Process Unit (PU), Technical Development (Tech Dev) Operations (OPS), Analytical Operations formerly known as Quality Control (AO) and Quality Assurance (QA) departments. <br><br>Your responsibilities will include, but are not limited to:<br>• Coordinates Qualification activities in compliance with corporate policy, local procedures and regulatory expectations<br>• Coordinates and develops with PU, Tech Dev, OPS, AO and QA teams qualification projects and plans and identifies the “critical to quality” parameters impacting qualification activities<br>• Prepares Qualification Master Plans, Risk and Impact Assessments, Protocols and Summary Reports and coordinates review and approvals of the documents <br>• Authors/reviews/updates/assists in developing departmental standard operating procedures (SOPs) and qualification programs <br>• Conducts field execution of Installation, Operational, Performance Qualification and Computer System Validation (CSV) protocols<br>• Assists PU, Tech Dev, OPS, AO and QA colleagues, as necessary<br>• Ensures that all activities are in compliance with cGMP, Health Authority regulations and the Novartis Policies<br>• Determines Qualification requirements based on a worst case matrix approach for the site<br>• Supports/assists 3rd party/ vendor qualification activities, when applicable<br>• Support qualification/validation projects as required<br><br><br>[#video#https://www.youtube.com/watch?v=Mo1vwtVPVA0{#400,300#}#/video#]<br><br>Vaccine Policy: While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com.