72 jobs found

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.   Location/Division Specific Information The St Louis site is a fast-paced, 24/7 biologic drug substance manufacturing facility with approximately 800 employees, by year-end, we will be closer to 1k due to a site expansion project going on now. Overall, this GMP facility is focused on cell process development to support the clinical phase and commercial manufacturing by producing products to treat a variety of chronic health conditions including cancers and other life-threatening diseases, as well as COVID-19.   Discover Impactful Work: The Downstream...

About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 90,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit  www.thermofisher.com .   At Viral Vector Services (VVS), a division of Thermo Fisher Scientific, we deliver from process development through commercial supply, we offer the...

Position Summary: This growth role is available in Manufacturing Science & Technology’s (MSAT’s) Process Validation department at Thermo Fisher Scientific. Qualified individuals will lead process validation activities for customer programs and will be responsible for planning and executing process validation studies in support of PPQ batches and commercial process optimizations. This role will be primarily responsible for authoring process validation protocols, overseeing study execution, analyzing the findings, and creating written reports summarizing the findings. This role will require cross-functional work with QA, operations, quality control and process engineering to ensure validation studies are performed appropriately according to site policies and regulations. This person has a core competency in process validation and experience with either upstream (cell culture) or downstream (protein purification) processes as well as experience working with...

Thermo Fisher Scientific Inc. is the world's leading science partner with $40 billion in sales and 100,000 employees in 55 countries. Our mission is to empower our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnosis and therapy, or increasing productivity in their laboratories, we are here to support them. At Patheon, part of Thermo Fisher Science in Linz, no two days are the same. The production of active pharmaceutical ingredients offers a wide range of tasks, regardless of whether you work in research, quality, production or in business. Together with more than 750 colleagues, you actively contribute to making this world a bit healthier.   Chemical Process Engineer m/w/d Region: Austria/Linz – international pharmaceutical company   As a chemical process engineer, you support our...

Position Summary: This growth role is available in Manufacturing Science & Technology’s (MSAT’s) Process Validation department at Thermo Fisher Scientific. Qualified candidate will help lead process validation activities for customer programs and will be responsible for planning and executing process validation studies in support of PPQ batches and commercial process optimizations with guidance. This role will be primarily responsible for authoring process validation protocols, overseeing study execution, analyzing the findings, and creating written reports summarizing the findings. This role will require cross-functional work with QA, operations, quality control and process engineering to ensure validation studies are performed appropriately according to site policies and regulations. The candidate has some experience with either upstream (cell culture) or downstream (protein purification) processes as well as experience working with single-use...

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. How will you make an impact? Under the the direction of manager or senior process engineer, assist the Manufacturing group to achieve site and departmental objectives. What will you do? Support the introduction and improvement of Manufacturing processes. Provide technical support to Engineering and other departments to support new equipment installations in Manufacturing. Perform process...

JOB SUMMARY:   This position is expected to be the Sr. MBR/PPQ Specialist of Drug Product department at Hangzhou site. Oversees and ensures the successful PPQ and MBR management in Drug Product department for the company.   Guarantee the production process of the injectable sterile pharmaceuticals is executed with the necessary robustness and the appropriate sterility assurance. Effectively arrange the Process Engineering activities including but NOT limited to: Process Performance Qualification, Master Batch Record management, Technique Transferring, Production handover etc. in conformity to the current SOP and the cGMP normative, safety & environment policy and labor law.   RESPONSIBILITIES: EHS Observe site EHS policy and rules and ensure the first goal of all employees is safety. Team and Employee Training Management -Provide related training course to the team: Ensure the constant and adequate level of training...

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information St. Louis, MO How will you make an impact? The Downstream Process Engineer is an expert (dependent on level) in the field of expertise (downstream processing) and is regarded as such within Thermo Fisher Scientific. The Process Engineer provides technological input in the transfer and development of a process and is the technical owner while running customer...

Position Summary: This position utilizes knowledge of engineering principles in connection with executing responsibilities to support Bio Process Plastic consumables operation in Thermo Fisher Scientific Suzhou factory, include production process design and optimization, Equipment verification/validation and maintenance, automation and digitalization application, capacity expansion and new capability and technology development, and employee training and other engineering related responsibilities. Essential Job Functions and Accountabilities :   Define production layout, keep improving the logistical route, Production capacity analysis and improvement. Develops PFEMA analysis for primary processes and new programs.   Responsible for establishing and optimize manufacturing processes, methods and procedures to assure product performance, quality and cost effectiveness. Responsibilities include acquisition, implementation and integration of new...

Monza site is a world class contract manufacturing and development facility, specialized in aseptic injectable drugs, with an increasing focus on biologics. Joining a global team and more than 1500 colleagues on site, the selected candidate will experience a smart, international, and fast-growing environment. With revenues of more than $30 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.   What you will do You will join a newly-established Manufacturing Process Engineering Team, to provide technical support and expertise to Production and Technology Transfer, to meet Client’s requests. In this role you will lead client’s projects from a technical standpoint for what concerns the manufacturing activities, assisting Technology Transfer Project Managers on customer technical transfers, modifications to existing processes or...

At the Plainville site within the Viral Vector Services (VVS), a division of Thermo Fisher Scientific, we deliver Advanced Therapeutics from process development through commercial supply, and we offer the expertise and resources vital to help clients deliver innovative gene therapies How will you make an impact? The Process Engineering II will be responsible for supporting the manufacturing equipment for upstream, downstream and fill/finish operations. The initial focus of the position will be supporting the execution of a large capital facility project from construction and operational readiness activities for a state-of-the-art new commercial manufacturing facility. This role will transition into primary manufacturing operations support role in the site Facilities and Engineering team where they will support manufacturing, laboratory, and warehouse operations. What will you do? In operations, the Process Engineer II is responsible for providing Support...

Key Responsibilities: Assist/engage in implementation of facility, equipment, and biotechnology process improvement projects. 实施设施、生物工艺设备和流程改进项目。 Engage in execution and writing of documents (specifications, protocols, and reports) related to facility, equipment, and process improvement of production process. 执行和编写与生产过程的设施、设备和过程改进相关的文件（规范、方案和报告）。 Engage in conduction of IQ, OQ, and PQ for new equipment. 执行新设备的IQ、OQ和PQ。 Modification of SOPs and BPRs for new processes in accordance with change control policies. 根据变更控制政策修改新工艺的程序和批记录。 Engage in in review BPR, SOP and logbooks for completion and insurance of accuracy of all documents as per GMP guidelines. 根据GMP 指南，参与检查批记录、SOP和辅助记录，以确保所有文件的完成和准确性。 Participate / lead in deviation investigations. 参与/主导偏差调查。 Lead/participate implementation of corrective and preventive actions in production. 主导生产中纠正预防措施的执行 Any other duties as assigned by your Supervisor/ Manager 主管/经理交代的其它任务。 Key Requirements: Bachelor’s...

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values pe​rformance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.   How will you make an impact? You will join the Manufacturing Engineering team where you will responsible for the qualification and improvement activities of BPC (Bio Product Chambers) manufacturing equipment and processes in support of the BPC production teams.   What will you do? Use engineering tools and methods such as DOE, FMEA, SPC and statistical analysis. Technical writing including engineering protocols and reports for standard and customised systems (URS, FAT, IQ, OQ, PV). Development and...

Location/Division Specific Information At the Plainville site within the Viral Vector Services (VVS), a division of Thermo Fisher Scientific, we deliver Advanced Therapeutics from process development through commercial supply, and we offer the expertise and resources vital to help clients deliver innovative gene therapies How will you make an impact? The Process Engineering III will be responsible for supporting the manufacturing equipment for upstream, downstream and fill/finish operations. The initial focus of the position will be supporting the execution of a large capital facility project from construction and operational readiness activities for a state-of-the-art new commercial manufacturing facility. This role will transition into primary manufacturing operations support role in the site Facilities and Engineering team where they will support manufacturing, laboratory, and warehouse operations. What will you do? In operations, the Process Engineer III is...

Purpose of the Position* 岗位目标 * Provide engineering support to CAPEX engineering & technical projects related with DS&DP production process computerized process equipment (CU equipment) including but not limited single chip machine, PLC/DCS, HMI, SCADA and MES . 为Capital原液和制剂生产工艺计算机化工艺设备项目(公用洁净系统)提供工程技术支持包含但不限于单片机，可编程逻辑控制器/分布式控制系统、触摸屏，SCADA以及制造执行系统。 Primary work load as automation SME focuses on process equipment’s FS, HDS and SDS review and approve to make sure the equipment running under control within the FS description duration the equipment life cycle. 作为自动化SME首要工作专注于工艺设备功能设计，硬件设计以及软件设计的检阅与批准，同时确保工艺设备在生命周期中依据功能描述的功能执行。 Make sure the electronic record and e-signature of each process equipment generated in upstream or downstream are data integrity, appropriate and trackable and fulfill the FDA 21 part11 regulation. 确保每台工艺设备所生成的电子记录与电子签名数据完整性，准确性以及可追述性,同时要完全满足FDA21 part11法规要求。 Propose the computerized system strategy of access control,...