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Engineering and Validation Specialist (Morris Plains, NJ) (347414BR)

Engineering and Architecture

Architectural Engineering



Morris Plains, New Jersey, United States

10. The number of dedicated and inspired professionals in the Engineering Services function who are empowered to ask new questions and make bold decisions to support bringing lifesaving medicines and treatments to patients. Come join our curious and unbossed team and make an impact on patient’s lives every day!<br>-----------------------------------------------------<br><br>You will ensure compliance to the regulatory requirements of the facilities, utilities, equipment and analytical instruments qualification processes, and activities performed in the Novartis, Morris Plains, NJ facility. <br><br>Recommend and implement improvements to the qualification process.<br><br>Perform a variety of routine and non-routine tasks related such as managing and coordinating qualification projects and changes: Prepare risk and impact assessments and other evaluations. Support Process Unit (PU), Manufacturing, Science and Technology (MS&T), Operations (OPS), Quality Control (QC) and Quality Assurance (QA) departments.<br><br>This includes the incumbent to: <br><br>1. Provides oversight to complex qualification activities and projects including the support of internal and external audits<br><br>2. Leads multifaceted qualification activities with limited oversight<br><br>3. Coordinates Qualification activities in compliance with corporate policy, local procedures, and regulatory expectations<br><br>4. Coordinates and develops with PU, MS&T, OPS, QC and QA Teams qualification projects and plans and identifies the “critical to quality” parameters impacting qualification activities<br><br>5. Prepares Qualification Master Plans, Risk and Impact Assessments, Protocols and Summary Reports and coordinates review and approvals of the documents<br><br>6. Authors/reviews/updates/assists in developing departmental standard operating procedures (SOPs) and qualification programs<br><br>7. Conducts field execution of Installation, Operational and Performance Qualification protocols<br><br>8. Ensures all activities follow cGMP, Health Authority regulations and Novartis Policies<br><br>9. Determines the Qualification requirements based on a worst-case matrix approach for the site and provides qualification solutions that meet regulatory requirements within budget, where applicable.<br> <br><br>[#video#{#400,300#}#/video#]<br><br><br>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