厦门招聘

The Senior Process Engineer supports pharmaceutical process development, scale-up and cGMP production of Active Pharmaceutical Ingredient (API).

Background

The senior process engineer will work on a multinational project to scale-up and optimize production of a pharmaceutical intermediate at a contract manufacturer (CMO). The companies involved, the technical expertise and the equipment vendors for this program are based in both the USA and China. The program is in need of an engineer who can communicate well with all parties and work with the contract manufacturer to implement the planned program. The engineer will lead the development activity for this project. He or she will spend extensive time in the plant of the contract supplier (in Fujian) and at other partner sites in Shanghai and elsewhere. The engineer will report to the president of Eastar Chemical and will have extensive participation with the US client.

Responsibilities

The senior process engineer will work closely with US and China based companies, vendors and experts to guide process scale-up, equipment design and selection, and process optimization at the contract manufacturer. He or she will meet with all parties to gain a fundamental understanding of all aspects of the project and will work with the CMO to guide implementation of the program.

The senior engineer will take the leadership role for process development, scaleup, equipment specification, and facility design. The engineer will work closely with the CMO to ensure that the process development is scientifically well executed and well documented. This will include developing experimental protocols, ensuring data and documentation are collected, and writing reports.

The ability to work respectfully, patiently, and in a collegial manner with people with a wide range of backgrounds, education and expertise is essential to this role. The engineer will also participate in weekly conference calls with the US client and will lead calls with Chinese vendors.

Specific responsibilities include:

· Provide strong scientific and process engineering leadership for the project. Think critically in designing, conducting and troubleshooting experiments and in designing equipment train.

· Develop a fundamental understanding of the chemical process, product requirements and specifications, equipment required to meet these specifications and project goals

· Develop a good working relationship with all parties

· Work with technical project team to develop process scale-up and process optimization experimental plans. Work with CMO to implement experimental plans with written protocols, batch records and reports. Follow up with CMO to ensure work is completed as scheduled.

· Participate in selection and testing of process equipment. Work with project engineers to modify design of process equipment. Work directly with equipment vendors and oversee custom equipment procurement.

· Work with engineering company to provide process and facility support as needed.

· Work with cGMP experts to ensure process development at CMO meets requirements of US FDA cGMP

· Create an environment where asking questions, reporting problems and admitting mistakes are encouraged.

· Work to keep all activities on-time and in-budget.

· Communicate frequently with project team, US and China based experts, and vendors. Be the interface between US and China as well as a strong team member.

Requirements

The process engineer must meet the following requirements

· BS/MS/PhD in chemical engineering or related discipline

· Minimum of eight years experience as a process engineer

· Minimum of five years experience in the pharmaceutical industry in a process engineering role

· Experience in process scale-up and optimization in pilot plant (or equivalent)

· Experience in project management and working on a project team

· Experience in a foreign (non-Chinese) pharmaceutical company highly desirable

· Understanding of GMP/ICH regulation highly desirable

· Experience in polymer chemistry/process development/engineering highly desirable

· Must have excellent written and oral communication skills in both Chinese and English

· Demonstrate a history of hard work and productive activity in support of organization goals

· Able to work at CMO in Fujian China at least 2 weeks/month

· Proven ability to work independently and as a strong team player

事达，在过去的30年中，已向中国客户成功提供了众多西方先进的产品和技术、cGMP认证咨询服务，和有助于客户的长远发展和稳步增长、并保持市场竞争力的项目规划服务。宜事达通过与美国、欧洲的化工医药行业建立的长期紧密的合作关系，使宜事达对市场有着深刻的洞察力，并熟知具有尖端、市场成熟的产品和强大组织结构的一流公司。宜事达通过与这些公司的紧密合作，使公司积累了丰富的经验，可以确保宜事达化工充分满足中国市场的需求。

宜事达化工由拥有强大网络资源和具有专业知识，并有着丰富医药行业业务经验的国际化管理层，以及一批训练有素的中国运营团队组成。这些条件得以确保我们不断的持续发展，并提供高科技、高品质的产品和技术。宜事达化工欧美和中国的所有员工向我们的客户及合作伙伴提供不可或缺的价值。
★在监管指导和项目规划方面由药学博士DanielGold领导，他指导中国制造商提高产品质量，获得客户的认可和西方国家管理机构的批准：如FDA认证，FCN，COS，EPA，Kosher, EH&S, REACH等。
★在技术许可方面由Jim Bruno领导，向中国生产商转让先进的西方技术和专利。
★在产品销售方面我们引入西方的优质产品，有助于提高中国药品市场的品质，提高消费者健康体质。
★在投资合作方面由Terry Mao 领导，同中国高科技公司及科研院合作，共同投资领先的、有竞争力的项目和技术。
★在专利支持方面有Todd Julliard 领导，协助中国生产商获得国际专利，并保护其免受西方公司的法律诉讼。
★我们与西方公司及创新者合作，提供极具有竞争力的产品：
       ○专利药品
       ○原料药和精细化工产品
       ○保健食品
       ○医疗器材
★我们的美国技术团队和实验室与欧美的研发伙伴合作，提供先进的西方精细化工产品、原料药、一般的和专利药品技术
★我们提供设备运作、法规（cGMP)以及专利服务和支持。

总之，宜事达是业内知名企业，具有一流的管理团队、业界资深的合伙人、多年的服务客户的成功记录。宜事达为客户提供有竞争力的价格和全方位服务，让您立于不败之地。