Engineer – Drug Product Clinical Supply Chain Job
Description
Pharmaceutical Development & Manufacturing Sciences (PDMS) in Beerse, Belgium is part of the global Janssen Research & Development organization within Johnson & Johnson and is currently recruiting for an :
Engineer – Drug Product Clinical Supply Chain
The PDMS Clinical Supply Chain holds the global responsibility all clinical supplies of Janssen Research & Development. Our activities include all in-house and outsourced planning, manufacturing and distribution of clinical supplies (API, Drug Product, Packaged Clinical Supplies), through a global network. We supply more than 60.000 patients in more than 300 clinical trials every year.
POSITION SUMMARY:
The function holder is an engineer responsible for leadership and in process control for the packaging and labeling of drug product clinical supplies from the Beerse campus. Integral to the role is the oversight of in process control and GMP activities necessary to reliably meet demand for clinical materials. The function holder will be exposed to numerous aspects of the business and well positioned for career advancement.
PRINCIPAL RESPONSIBILITIES:
- Responsibility for day to day in process control activities in a (2) shift regime for primary and secondary packaging activities
- Execute packaging order start up, material checks, reconciliations, unblinding checks, batch record reviews and in process testing
- Ensures the team activities execute against annual targets for service, cost, quality, compliance
- Supports adherence to the master production schedule to ensure reliable and timely supply for clinical trials
- Preparation of batch document and labels
- Drive continuous improvement projects such as 5S and Lean within the operational team
- Support review of work instructions, events, deviations to drive quality improvements based on quality metrics
- Execute packaging order start up, material checks, reconciliations, unblinding checks, batch record reviews and in process testing
- Ensures the team activities execute against annual targets for service, cost, quality, compliance
- Supports adherence to the master production schedule to ensure reliable and timely supply for clinical trials
- Preparation of batch document and labels
- Drive continuous improvement projects such as 5S and Lean within the operational team
- Support review of work instructions, events, deviations to drive quality improvements based on quality metrics
Qualifications
- You have a University Bachelor Life Sciences, Pharmacy or Engineering degree, or equivalent through work experience.
- Familiarity with Quality Assurance and Regulatory Compliance cGMP and EH&S
- Ability to provide hands on support with focus on safety, quality and productivity
- You are flexible and with a sense of urgency when working in a development environment.
- You have good communication skills and you are a good team player able to collaborate with different departments (e.g. planning, batch doc & label group, in process controllers, engineering and technical services)
- You can work with Word, excel and powerpoint and are able to learn our internal operating system (NgenCodac)
- You have strong affinity with managing operators and you can show strong leadership
- Proficiency in English and Dutch is required
- Familiarity with Quality Assurance and Regulatory Compliance cGMP and EH&S
- Ability to provide hands on support with focus on safety, quality and productivity
- You are flexible and with a sense of urgency when working in a development environment.
- You have good communication skills and you are a good team player able to collaborate with different departments (e.g. planning, batch doc & label group, in process controllers, engineering and technical services)
- You can work with Word, excel and powerpoint and are able to learn our internal operating system (NgenCodac)
- You have strong affinity with managing operators and you can show strong leadership
- Proficiency in English and Dutch is required
We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure. If you are interested in this position, then please apply online including application letter, CV and ideally testimonials.
- CBLD-BE
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: R&D Engineering (R&D)
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: R&D Engineering (R&D)
To apply, please click here.
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