职位信息

招贤纳士

职位信息

Lead - Environmental Monitoring

立即申请

Dec. 03, 2020

Lead - Environmental Monitoring

中国

Leverkusen

工作职责：

Lead or participate microbiology projects, including microbial testing, environmental monitoring, viable and non-viable particles, water monitoring, compressed gas (Air and N2), pure steam, and testing including endotoxin and bioburden, supporting facility qualification, process validation, etc.
Serve as a technical expert to lead OOS, OOL, microbial contamination, adverse trends, utility and environmental excursion investigations, change controls, and CAPAs.
Author technical documents including methods protocols, qualification/ validation protocols and reports, SOPs, etc.
Provide microbiological technical expertise, trouble-shooting, training and support to the laboratory team in the qualification and execution of environmental monitoring,
Perform Risk Assessments for environmental monitoring related activities.
Play a lead and proactive role in the design, maintenance, and training aseptic technique and microbiology awareness training.
In conjunction with manufacturing, help improve training related to microbiological hygiene and contamination prevention.
Expected to be a point of contact for project coordination, including email and client meetings.
Ability to handle regulatory inspections from FDA, EMA, etc. and cGMP audits from clients, as well as internal audits.
Planning for future requirements in both Manufacturing and the QC area.
Participate in relevant internal and external QC related audits.
Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Biologics Policies and Standard Operating Procedures.
Thorough understanding of current Good Manufacturing Practices

任职能力：

Ph.D., MS or BS in Microbiology or related field
MS with minimum 4 years, BS with minimum 7 years of microbiology experiences in pharmaceutical industries
Previous experience in a Quality Control/GMP environment is a plus
Excellent Oral & Written communication skills (English and German)
Be familiar with requirements of FDA, EMA regulations; ICH and GMP guidelines
Knowledge of environmental monitoring in support of biopharmaceutical manufacturing
Ability to think critically and demonstrate troubleshooting and problem solving skills
Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities

其他要求:

Are you interested in becoming part of this culture and actively shaping the future of WuXi Biologics?

Then we look forward to receiving your application documents (CV in German and English), stating your salary expectations and the earliest possible starting date.

Please send your application by e-mail to: Recruiting_Germany@wuxibiologics.com

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