Improvement Engineer Biotech DSP (Downstream Processing) - Environmental Monitoring
The Biotech department is located in North-Brabant in NL. Over 2000 employees work in the pharmaceutical, chemical and biotechnological production. Within the Biotech department, novel biologic active ingredients ("Drug Substance") are manufactured, including medicines for fertility, diabetes, and oncology.
Within Biotech, there are two Integrated Product Teams (IPTs) - responsible for Upstream Processing (USP) and Downstream Processing (DSP) operations. The active ingredients produced in USP are purified in DSP to pure Drug Substance. Their clean room facilities are 24/7 operated to provide OTIF treatment to patients globally The DSP IPT supports the manufacturing of both licensed commercial biologic products as well as new novel biologic products being developed to meet un-met medical needs.
Primary tasks/ responsibilities
- Support and manage the routine Environmental Monitoring (EM) activities in our cleanrooms and (Clean) Utility Monitoring (UM) programs on a daily basis;
- Coordinate and resolve Quality Notifications (events) related to EM and UM excursions;
- Define and implement corrective and preventive actions;
- Execute improvements in business processes, leveraging lean six sigma and/or Kata mind-set;
- Direct oversight on EM technicians and responsible for development of the EM group;
- Trending of EM and UM data including annual reporting;
- Represent the IPT during internal-, client- and external audits and inspections for EM and UM related matters;
- Closely interact with and support manufacturing and quality personnel in all aspects of EM observations, process improvements and investigations;
- Develops and maintains site policies and procedures related to EM and UM ensuring compliance to corporate and regulatory standards;
- Maintain current knowledge of regulatory and industry standards, trends and advancements in EM and UM.
- Bachelor's or Master's degree in Microbiology, Biotechnology, Biochemistry, Engineering or equivalent;
- At least 3 years of experience in aseptic or sterile processing in cleanrooms with high focus on microbiology (highly preferable);
- Experience in Root Cause Analysis and facilitate Lean Six Sigma tools;
- Thorough understanding of cGMP, Regulatory expectations, and international industry guidelines;
- Ability to work independently with minimum supervision;
- Engage and coach team to solve problems, continuously developing problem solving skills;
- 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.
Progressive Recruitment is gespecialiseerd in de bemiddeling van professionals binnen de sectoren IT, Global Energy & Natural Recources, Life Sciences, Supply Chain en Engineering. Wij kunnen je helpen bij je zoektocht naar een tijdelijke opdracht, maar ook als je zoekt naar een permanente functie in deze sectoren. Kijk voor meer informatie op www.progressiverecruitment.com of www.progressivege.com
Progressive Recruitment is specialized in recruiting professionals in the sectors IT, Global Energy & Natural Recources, Life Sciences, Supply Chain and Engineering. We can help you find temporary and permanent job opportunities in these industries. For more information, visit www.progressiverecruitment.com or www.progressivege.com.