合肥招聘

Lead Validation Engineer

Working Location: Shanghai

 

Responsibilities:

Develop and execute the validation package, which includes the following:

Validation Plan

Requirements Specifications

Hardware Qualification Documents

Hardware Install

System Configuration Baseline Documents

System Use SOP

System Management SOP

Performance Qualification Protocol

Performance Qualification Report

Traceability Matrix

Summary Report

Training

System Release Document

 

Requirements:

At least 10+ years in the FDA-regulated biotech/pharmaceutical industry.

Significant project lead experience.

Significant experience generating and executing Validation Life Cycle documents such as Val Plans, URS, IQ/OQ, PQ, & UATP.

Knowledge of 21 CFR Part 210 & 211.

Proven ability to resolve quality issues/discrepancies with others in a constructive manner is essential.

Ability to work as a team player in a consulting environment.

Must be able to work independently with minimal supervision.

Strong written, communication, and interpersonal skills.

美施威尔集团是一家跨国的工程公司，在行业中占主导地位。它为在微电子、平面技术、光伏、生物制药及新能源等高科技领域的全球知名的企业提供复杂的工程及设备方案。美施威尔集团的总部位于德国斯图加特市。在全球范围内拥有40多家子公司，主要分布于美国区、欧洲区及亚太区，有8100多名正式雇员。

美施威尔（上海）有限公司作为美施威尔集团在亚太区的独资子公司，在中国成立于1994年。拥有机电总包一级资质及建筑总包二级资质。主要经营范围是在微电子、平面技术、光伏、生物制药及新能源等高科技领域提供全方位的咨询、设计、施工和运营服务。美施威尔(上海)有限公司以信誉、文化多元化、以员工为骄傲、以人与环境为本、以客户为导向以及信任作为其秉承的核心价值观。

随着十九年在中国的持续快速发展，正式雇员已经发展至500多名。为今后更快的发展及成功，我们诚邀下列人才加入我们的团队。公司将提供具有竞争力的薪资待遇及良好的职业规划。

M+W Group is the global engineering company on the leading position to provide the comprehensive solution of facility engineering and high-tech manufacturing facilities for the clients in the industries of semiconductor, flat panel, photovotac, life science and nutrition, new energy etc. The head quarter of M+W group is located at Stuttgart, Germany. In worldwide it owns around 40 subsidiaries, divided into three business unit, including America Unit, Europe Unit and Asia Pacific Unit, and with more than 8100 employees.

M+W (Shanghai) Co., Ltd is the wholly foreign owned subsidiary of M+W Group in Asia Pacific which was established by 1994 in China. It possessed general contractor CQC license of Grade A for ME and Grade B for building. The business scope of M+W Shanghai is to provide the engineering and construction service in whole China in the industries of semiconductor, flat panel, photovotac, life science and nutrition, new energy etc. The core value of M+W Group includes Credibility, Cultural Diversity, Pride in our Employees, People and Environment, Customer Orientation and Trust.

With 19 years continuous fast growing in China, M+W Shanghai is with more than 500 employees. For further growth and success, we sincerely invite the following talents to join our team. We will offer good career and competitive remuneration package for the successful applicants.