Technical Steward, Packaging job in Hicksville
|Employer:|| Novartis Pharmaceuticals|
|Job Type:||Full Time|
|State:||New York (NY)|
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field. We're committed to peak performance, improving the quality of life, and embracing and leveraging diverse backgrounds, cultures and talents to achieve competitive advantage. |
Provides to the Site the specialist knowledge, as Subject Matter Expert, of packaging processes or technologies, includes primary and secondary packaging of semi-solids and liquids in tubes, bottles, jars, others.
Oversees processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.
Act as the SPOC for the interface with global MS&T network and with technical development organization, for the corresponding global activities, to define and implement new technical standards for existing and new technologies and equipment.
Owns the knowledge of specific packaging process technologies, locally, including any pilot scale, scale up or down, and Design of Experiments (DoE).
Participate in the definition and selection of pharmaceutical equipment, through providing input to User Requirements.
Collaborate with technical development, other sites and global MS&T network to facilitate transfer of technical knowledge.
Assure that the necessary benchmark is done internally in Novartis, and externally in the scientific and academic environment, in order to stimulate and to extend the knowledge, increasing the know-how of the associates and expanding it to the rest of the organization.
Be a recognized scientific expert internally and externally by reporting and presenting scientific/technical work at internal/external meetings/conferences and publish in peer reviewed international scientific journals including patents.
Provide technical expertise to Engineering for design activities in Capex projects around technologies within area of responsibility.
Provide technical expertise for equipment qualification around technologies within area of responsibility.
Approve validation reports under their area of responsibility (as needed) e.g. packaging validation.
Provide technical expertise for validation activities around technologies within area of responsibility.
Launch & Transfer: SME for specific Technology Platform or pharmaceutical processes following process product/process transfer or handover from launch to commercial production. Manufacturing Excellence- for the technology(ies) assigned: Harmonize and optimize technical processes across the site. Benchmark new technologies and equipment relevant for site. Designs and controls optimization projects.
Provide SME expertise to perform process characterization of the related packaging processes to increase robustness and sustainability.
Support Product Stewards / Process Experts in trouble shooting / root cause investigation by providing second level of specialist expertise as SME and by harmonizing and optimizing related technical processes across the units.
Perform technical feasibility trials related to process improvement and implementation of new packaging technologies.
Batch release on time/in quality. Line throughput time. Deviations - process-related.
Effective CAPAs. Ppk/CpK - process capability. OoS, OoE - Out of Specification, Out of Expectation - process-related. Yield. Customer Complaints - process-related. Recalls - process-related. Success rate of internal audits and Health Authorities' inspections.BSc. in Packaging Engineering or Mechanical Engineering or Engineering required
Minimum 5+ years experience in GMP manufacturing relevant to the specialist area of expertise. Proven process understanding (Pharma, GMP, Regulatory aspects).