Process Engineer III, Manufacturing Sciences

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🕒 il y a 16 jours

🏰 Missouri – Distant

🏰 Missouri – Remote

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👷🏻‍♀️ Ingénieur

🦅 Parrain de Visa H1B

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Thermo Fisher Scientific

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1956

🏥 Santé

📦 Logistique

🏭 Fabrication

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific est le leader mondial dans le service aux sciences, avec un chiffre d'affaires annuel de plus de 40 milliards de dollars. Leur mission est de permettre à leurs clients de rendre le monde plus sain, plus propre et plus sûr en soutenant la recherche en sciences de la vie, en résolvant des défis analytiques complexes, en augmentant la productivité des laboratoires et en améliorant la santé des patients grâce aux diagnostics et au développement de thérapies révolutionnaires. Avec une équipe mondiale, ils offrent des technologies innovantes et des services pharmaceutiques à travers des marques telles que Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon et PPD.

Description

• Provide technological input in the development, validation, and transfer of manufacturing processes. • Support the Process Engineering team as technical owners of customer programs in a manufacturing environment. • Collaborate internally with supervisors and technicians in the Operations department, Quality Assurance, fellow Engineers, and scientists in Process Development and with the client as a Process Engineer program lead. • Draft, review and approve Standard Operation Procedures, and Job Aids and consult internally to ensure scientifically sound and robust procedures. • Collaborate with the process development to develop standardized methodologies and learn/explore new methodologies for conducting unit operations at the manufacturing scale including cell culture, harvest, and purification. • Contribute to Internal and Customer meetings based upon sound evidence guided by minimal supervision. • Manage internal projects and tasks and lead client projects and manage timelines with minimal support from supervision. • Actively identify error proofing opportunities and initiate and drive engineering initiatives to improve practices and procedures with minimal supervision. • Provide scientific expertise for GMP deviations by assessing, reviewing and approving the impact of major deviations on both the product quality and the validation of the process. • Lead changes to equipment and process design, proactively and with minimal supervision. • Draft, review and approve Manufacturing Batch Records, Performance Qualifications, Process Validation protocols, process flow diagrams, automation methods, and Bill of Materials, ensuring the process is technically accurate and designed for Manufacturing. • Draft, review, and approve Process control documents, campaign summary report and process validation reports. • Review, analyze and trend process data without supervision. • Provide technical feedback on documents created by other departments, such as Tech Transfer Protocols and SOPs. • Troubleshoot technical challenges on the manufacturing floor as needed for a 24/7 manufacturing facility. • Support our MSAT team with additional tasks to improve the site, ensure patient safety, and deliver for our customers. • Provide development and training for Process Engineers/Scientists.

🎯 Exigences

• Bachelor’s degree required in a scientific field, preferably an engineering field. • 5+ years of experience in GMP regulated Biologics / Pharma Industry, or equivalent experience (or master's degree in a scientific field + 3 years' experience or Ph.D.). • Follow Environmental, Health and Safety policies and procedures and ensure a safe and healthy workplace environment. • Ability to self-motivate, prioritize work and time. • Demonstrates a foundation in general scientific practices, principles, and concepts. • Writes and communicates effectively. • Ability to work both independently and as part of a team. • Knowledge of current Good Manufacturing Practices and US/EU regulations. • Intermediate knowledge of statistical methods used for Pharmaceutical Process Analysis is a plus. • Proficient in Microsoft Word and Excel. • Ability to stand for prolonged periods of time and gown into manufacturing areas.

🏖️ Avantages

• Adherence to all Good Manufacturing Practices (GMP) • Safety Standards • Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)