Process Engineer ( Site Based in Villa Guardia )
Villa Guardia | careers.jazzpharma.com |
Overview:
Jazz Pharmaceuticals è un’azienda biofarmaceutica globale impegnata nello sviluppo di farmaci rivoluzionari per persone affette da gravi patologie, per le quali le opzioni di trattamento sono limitate o pressoché inesistenti. Abbiamo un portafoglio diversificato di farmaci già in commercio e di potenziali nuovi prodotti, in fase di sviluppo iniziale e avanzata, in aree terapeutiche fondamentali.
La nostra attenzione è rivolta alle neuroscienze, nei settori della medicina del sonno e dei disturbi del movimento, e all'oncologia, in particolare per quanto riguarda i tumori ematologici e quelli solidi. Esploriamo attivamente opzioni di trattamento originali, dai nuovi composti alle migliorie nel settore delle piccole molecole, ai biofarmaci, alle tecnologie di somministrazione innovative.
Con sede a Dublino, in Irlanda, Jazz conta addetti a livello mondiale che operano in oltre novanta paesi.
Siamo alla ricerca dei talenti più qualificati e brillanti da inserire nel nostro team. Chi fosse interessato a far parte di un’azienda che si distingue per l’impegno incrollabile a migliorare la vita dei pazienti e per il prestigio dell’ambiente di lavoro è invitato a valutare le nostre offerte di lavoro e ad informarsi per conoscere meglio Jazz Pharmaceuticals.
Position Profile:
Brief Description:
The Process Engineer is a key role in the Technical Services Department within the global Manufacturing, Science and Technology Group (MS&T). The role will provide technical and scientific leadership to introduce new biologics products/process and to improve existing processes in compliance with current pharmaceuticals standards.
The role will require close collaboration with all functional areas of the technical operations team including Product and Process Design, Process Automation, Facilities Engineering, Quality Controls, Quality Assurance, Supply Chain, Manufacturing and EHS
Essential Functions/Responsibilities
• Support technology transfer of processes into manufacturing for both internally and externally developed processes.
• Work cross functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other departments to effectively transfer and maintain processes in the facility.
• Work closely with manufacturing to author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing.
• Lead and/or support the compilation of process data, including communicating project status, trend identification, and delivering internal or client presentations.
• Evaluate existing processes and identifies process or equipment improvements to advance efficiency, consistency, and competitiveness within the market.
• Author and review documents including batch production records, tech transfer reports, bill of materials, process descriptions, project reports, engineering specifications, and summary reports.
• Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.
Required Knowledge, Skills, and Abilities
• Significant experience in pharmaceutical development and manufacturing with a strong background in both small and large molecule technologies.
• Extensive knowledge and experience with late-stage clinical and commercial biologics drug substance and drug product manufacturing programs, in both small and large molecule
• Proven project leadership roles in process validation, PPQ, and commercial manufacturing.
• Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology is required.
• Proven experience on cell culture, purification, and solution preparation operations using disposable-based manufacturing technologies.
• Ability to deliver objectives on time in pressurized, fast paced environments, whilst also meeting all compliance, quality, and cost targets.
• Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing.
• Good interpersonal, team, and collaborative skills are required.
• Excellent verbal and written communication skills in English; ability to interface with all levels of the organization.
• Strong understanding of Environmental, Health & Safety Requirements
• Strong understanding of Quality System Requirements
• Foster a culture of change, innovation and self- improvement to maximise achievement of overall site goals
Required/Preferred Education and Licenses
• Ph.D. (or Masters) degree in relevant in Chemistry, Pharmaceutical Science, Biotechnology, Chemical Engineering or related field and preferably with 10+ (15+) years in a pharmaceutical or biotechnology CMC/cGMP environment
Jazz Pharmaceuticals is an Equal Opportunity Employer.
Jazz Pharmaceuticals è un’azienda biofarmaceutica globale impegnata nello sviluppo di farmaci rivoluzionari per persone affette da gravi patologie, per le quali le opzioni di trattamento sono limitate o pressoché inesistenti. Abbiamo un portafoglio diversificato di farmaci già in commercio e di potenziali nuovi prodotti, in fase di sviluppo iniziale e avanzata, in aree terapeutiche fondamentali.
La nostra attenzione è rivolta alle neuroscienze, nei settori della medicina del sonno e dei disturbi del movimento, e all'oncologia, in particolare per quanto riguarda i tumori ematologici e quelli solidi. Esploriamo attivamente opzioni di trattamento originali, dai nuovi composti alle migliorie nel settore delle piccole molecole, ai biofarmaci, alle tecnologie di somministrazione innovative.
Con sede a Dublino, in Irlanda, Jazz conta addetti a livello mondiale che operano in oltre novanta paesi.
Siamo alla ricerca dei talenti più qualificati e brillanti da inserire nel nostro team. Chi fosse interessato a far parte di un’azienda che si distingue per l’impegno incrollabile a migliorare la vita dei pazienti e per il prestigio dell’ambiente di lavoro è invitato a valutare le nostre offerte di lavoro e ad informarsi per conoscere meglio Jazz Pharmaceuticals.
Position Profile:
Brief Description:
The Process Engineer is a key role in the Technical Services Department within the global Manufacturing, Science and Technology Group (MS&T). The role will provide technical and scientific leadership to introduce new biologics products/process and to improve existing processes in compliance with current pharmaceuticals standards.
The role will require close collaboration with all functional areas of the technical operations team including Product and Process Design, Process Automation, Facilities Engineering, Quality Controls, Quality Assurance, Supply Chain, Manufacturing and EHS
Essential Functions/Responsibilities
• Support technology transfer of processes into manufacturing for both internally and externally developed processes.
• Work cross functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other departments to effectively transfer and maintain processes in the facility.
• Work closely with manufacturing to author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing.
• Lead and/or support the compilation of process data, including communicating project status, trend identification, and delivering internal or client presentations.
• Evaluate existing processes and identifies process or equipment improvements to advance efficiency, consistency, and competitiveness within the market.
• Author and review documents including batch production records, tech transfer reports, bill of materials, process descriptions, project reports, engineering specifications, and summary reports.
• Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.
Required Knowledge, Skills, and Abilities
• Significant experience in pharmaceutical development and manufacturing with a strong background in both small and large molecule technologies.
• Extensive knowledge and experience with late-stage clinical and commercial biologics drug substance and drug product manufacturing programs, in both small and large molecule
• Proven project leadership roles in process validation, PPQ, and commercial manufacturing.
• Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology is required.
• Proven experience on cell culture, purification, and solution preparation operations using disposable-based manufacturing technologies.
• Ability to deliver objectives on time in pressurized, fast paced environments, whilst also meeting all compliance, quality, and cost targets.
• Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing.
• Good interpersonal, team, and collaborative skills are required.
• Excellent verbal and written communication skills in English; ability to interface with all levels of the organization.
• Strong understanding of Environmental, Health & Safety Requirements
• Strong understanding of Quality System Requirements
• Foster a culture of change, innovation and self- improvement to maximise achievement of overall site goals
Required/Preferred Education and Licenses
• Ph.D. (or Masters) degree in relevant in Chemistry, Pharmaceutical Science, Biotechnology, Chemical Engineering or related field and preferably with 10+ (15+) years in a pharmaceutical or biotechnology CMC/cGMP environment
Jazz Pharmaceuticals is an Equal Opportunity Employer.
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