Environmental Monitoring Specialist (Environment Health & Safety)
Location: Netherlands, Oss
Duration: +/- 4 months
Start: Preferably ASAP (1 dec 2020)
Team: Environment Health & Safety P&O Support - Quality
For a big multinational pharmaceutical company we are currently looking for a Environmental Monitoring Specialist. This is a temporary position (maternity leave).
In the IPT USP you are responsible for the quality in the production. It is important that you have a background in microbiology or biotechnology and have knowledge of clean rooms / aseptic processes in order to ensure that the environment in the production is and remains clean. In this role you are responsible for handling the QN, writing trend reports, handling corrective and preventive actions. You work closely with the improvement engineer, who implements improvements in the department based on your data.
Highlights for the position are therefore: knowledge of micro, biotech, cleanroom and handling of reports.
The Environmental Monitoring Specialist provides direct Technical Services to a production area as part of an IPT (Integrated Production Team) operating model. The EMS with guidance from the IPT Technical Services Leadership team, ensures product / process quality and performs activities to facilitate the release of product to the marketplace. The EMS is responsible for the review and evaluation of routine and per process environmental monitoring (EM) sampling of classified areas, and leads all investigations into environmental excursions. This position also works closely with the assigned end-to-end IPT in a team environment to ensure timely completion of responsibilities, creation of effective corrective/preventative actions, with emphasis on right first time.You will become knowledgeable in Federal and other regulatory agency requirements and GMPs to assure that all areas operate in a state of compliance. Works with moderate work direction and is skilled and knowledgeable to the position.
• Coordinate and resolve Quality Notifications (events) related to EM and UM excursions;
• Define and implement corrective and preventive actions; • Trending of EM and UM data including reporting;
• Able to collect data, interpret and translate to periodic reports
• Closely interact with and support manufacturing and quality personnel in all aspects of EM observations, process improvements and investigations;
• Maintain current knowledge of regulatory and industry standards, trends and advancements in EM and UM
• Experience with Environmental Monitoring. Previous experience in an aseptic manufacturing environment. Attention to detail.
• Minimum BSc in Microbiology, Biotechnology, Biochemistry, Engineering or equivalent;
• Minimum of 2 years of experience in aseptic or sterile processing in cleanrooms with high focus on microbiology (highly preferable);
• Experience in Root Cause Analysis
• Experience to work with common programs like MS excel and word
• Thorough understanding of cGMP, Regulatory expectations, and international industry guidelines;
• Ability to work independently with minimum supervision; • Must be proactive, results oriented, and have a strong attention for detail;
• Analytical and organizational mindset;
• Project Management skills (preferably);
• Strong people and communication skills to communicate with all layers of the organization;
• Excellent verbal and written communication skills in both Dutch and English language.
Are you interested or do you know somebody who would be interested in this role? Do you want to know more about this position? Do not hesitate and contact me!