Staff Engineer, Process Systems

🕒 vor 4 Tagen

🏄 California – Remote

🏄 California – Remote

💵 $157.000 - $183.000 / Jahr

⏰ Vollzeit

🔴 Experte

⚙️ Systemingenieur

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Vaxcyte

WebsiteLinkedInAlle Stellen

201 - 500 Mitarbeiter

Gegründet 2013

🏥 Gesundheitswesen

🏭 Fertigung

🧬 Biotechnologie

Healthcare • Manufacturing • Biotechnology

Vaxcyte ist ein Unternehmen für Impfstoffinnovation in der klinischen Phase, das Hochpräzisions-Impfstoffe zur Verhütung und Behandlung schwerer bakterieller Infektionen entwickelt. Das Unternehmen entwickelt Breitband-Konjugat- und neuartige Proteinimpfstoffe, indem es moderne synthetische Chemie und eine proprietäre zellfreie Proteinproduktionsplattform nutzt, die von Sutro Biopharma lizenziert wurde, um schwer herzustellende Proteinantigene effizienter zu erzeugen. Die Hauptprogramme sind die Pneumokokken-Konjugat-Impfstoffkandidaten VAX-31 (31-valent) und VAX-24 (24-valent) in Phase-2/3-Studien, mit weiteren Kandidaten in frühen Entwicklungsstadien, die auf Gruppe-A-Strep und Shigellen abzielen. Vaxcyte konzentriert sich darauf, die Belastung durch invasive bakterielle Krankheiten, die Folgen von Antibiotikaresistenzen und damit verbundene Morbidität in gefährdeten Bevölkerungsgruppen zu reduzieren.

Beschreibung

• Lead and manage all engineering activities for advanced biotechnological systems, including utilities, process equipment, automation systems, and facilities. • Work on significant and unique issues where analysis of situations or data requires an evaluation of intangible variables and may impact future concepts, products or technologies. • Review and approve process equipment documentation, such as protocols, test plans, reports, and other deliverables, ensuring alignment with company standards and regulatory requirements. • Conduct comprehensive risk assessments and design strategies to validate and optimize critical process parameters in compliance with industry standards and regulatory guidelines. • Lead complex system and equipment inspections, including FATs (Factory Acceptance Tests), SATs (Site Acceptance Tests), and IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification), ensuring precision and compliance. • Lead engineering feasibility studies, conceptual & basic design activities for projects across a range of products and sites. • Direct and manage validation initiatives, ensuring compliance with cGMP, FDA, EMA, and other applicable regulatory agencies. • Oversee the review and approval of validation protocols, plans, and reports, ensuring their alignment with industry standards and ensuring robust and reliable processes. • Analyze complex validation data to identify critical trends, continuously improving the reliability, efficiency, and compliance of validated systems. • Create formal networks with key decision makers and serve as an external spokesperson for the organization with CDMO and supplier partners. • Oversees the activities of a project and teams involved in cross-functional engineering projects from conception through completion, balancing complex timelines, budget constraints, resource allocation, and quality standards. • Collaborate effectively with senior project managers, cross-functional teams, contractors, and external vendors to coordinate, prioritize, and execute engineering activities. • Provide strategic technical leadership and foster a culture of innovation, collaboration, and continuous improvement. • Ensure project deliverables are met within scope and timeline while maintaining focus on compliance, quality, and cost-effectiveness.

🎯 Anforderungen

• Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Biomedical, or related field) or Biotechnology with a minimum of 10+ years of experience in Bioprocessing/Process Engineering within the biotechnology, pharmaceutical, or biopharmaceutical industry. Other combinations of education and/or experience may be considered. • Proven leadership experience in managing teams and large-scale Capex projects, including utilities, process equipment, and automation systems. • Extensive knowledge of biopharmaceutical manufacturing processes and equipment, particularly DCS, ISA-88 batch process control, and PLC-based control systems. • Demonstrated success in managing engineering activities for large-scale or complex facilities under tight timelines and budget constraints. • Expertise in drug product manufacturing and associated unit operations including compounding, automated visual inspection, assembly, labelling & packaging. • Expert-level knowledge of cGMP, FDA, EMA, ICH guidelines, and other global regulatory requirements. • Strong understanding of bioprocessing, including upstream and downstream processing, aseptic processing, and sterilization techniques. • Advanced proficiency in statistical analysis, risk assessment methodologies, and process validation best practices. • In-depth experience with quality management systems (QMS) and electronic documentation systems to maintain compliant documentation and support audit activities. • Capability to support and, when required, perform a range of broader engineering functions and activities, including project management, process optimization, automation, and utilities engineering. • Exceptional leadership, communication, and interpersonal skills, with the ability to influence at all levels of the organization and external partners. • Strong problem-solving, analytical thinking, and decision-making capabilities, especially in high-pressure environments. • Ability to prioritize and manage multiple complex projects, balancing conflicting demands while ensuring regulatory compliance and business goals. • Excellent mentoring and coaching abilities, fostering a culture of innovation and continuous improvement.

🏖️ Vorteile

• The compensation package will be competitive and includes comprehensive benefits and an equity component.