Validation Specialist

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. <br>We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!<br>Imagine what you could do here at Novartis! <br><br>The Validation Specialist has responsibility for executing and managing equipment, facility, utility, process, primary packaging validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expectations. <br><br>Your responsibilities include, but are not limited to: <br><br>• Support site validation planning by writing and maintaining master plans for projects and the site including equipment, facility, utilities, processes, cleaning, packaging processes and ongoing verification for processes and cleaning (as applicable). <br>• Support site lead in maintaining the process control strategy. <br>• Support drafting of CSV activities for lab and manufacturing equipment.<br>• Supporting on going qualification activities of VHP qualification, smoke studies, temperature mapping, room qualification. <br>• Design, execute and document experiments (formulation / analytical tests etc.) for products assigned in the context of process transfer, process improvement and process validation. <br>• Prepare and review appropriate GxP documentation including change requests. <br>• Identify improvement options of current processes, propose business case<br>• Translate applicable process parameters and the process control strategy into a focused validation plan for process validation. <br>• Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed). <br>• Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing process verification (OPV). Ensure that appropriate variables are identified for on-going monitoring as a contributor to quality risk management activities. <br>• Work in close collaboration with development organization (or sending site) for technical transfers and new product launches to ensure that knowledge is transferred, control strategies are appropriate, risks are analyzed and controlled and to ensure that commercial processes are validation ready <br>• Comply with applicable GxP regulations, SOPs, HSE, ISEC & other Novartis Guidelines in the laboratory and, Maintain up-to-date documentation of laboratory work carried out including documentation storage and archiving. -Contribute to and maintain lab instructions, SOPs, templates. -Support, qualification and calibration of lab / pilot equipment with accompanying documentation. <br>• Contribute to the evaluation of new equipment. <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.