Pfizer Inc. is a research-based company, known as the number one global biopharmaceutical giant. They apply science and global resources to bring therapies to people that extend and significantly improve their lives through the discovery, development and manufacturing of healthcare products. The global portfolio includes medicines and vaccines, as well as many of the world’s best-known consumer healthcare products.
Due to the fast growth of the Production Plant and transition into the Medical Device market, we are looking for Engineers with a Medical Device.
We are looking for a quality, process or project engineer that will report to the Senior Manager Center for Secundary Packaging. CSP is responsible for packaging sterile products, biotech products and associated devices.
Main tasks and responsibilities:
• You define and optimize of packaging systems with an audit ready and compliant packaging system in mind.
• You execute of regular reviews of the relevant Pfizer quality standards.
• You map potential quality and compliance gaps and implement corrective action plans.
• You prepare and coordinate internal and external audits.
• You follow up on QAR’s and CAPA’s and proactively discuss with QA which information is still missing or needs to be looked at closer.
• You define CAPA’s.
• You work in close cooperation with and are first point of contact for supervisors, coordinators and PE’s of a cluster of packaging lines for quality related issues.
• You document possible quality breaches in gQTS.
• You conduct complex research and are able to lead cross functional research teams when several departments should be involved.
• You are responsible for quality related action- and improvement plans.
• You define and optimize de GPM packaging methods-systems and – procedures (EBR, SOP’s, WI’s etc.).
• You are co-responsible to bring the quality systems, production controls, ways of conducting quality related research etc. in line with regulations and requirements of the Medical Devices & Combination Products (MDCP) standards
• You have a Master’s degree in a scientific field (bio-engineer, pharmacist, civil engineer, biology, chemistry, …).
• You should have a minimum of 3 years of experience in a medical device environment.
• Experience within a quality department and/or production department in combination with packaging expertise is a strong plus.
• Being fluent in Dutch and English is a must.
• Knowledge and experience of DMAIC or 6 Sigma is a plus
• You have thorough understanding of regulations of medical devices or combination products.
• You possess excellent social skills and are a team player.
• You are a strong communicator in both English and Dutch.
• You have coaching skills.
• You are punctual with an eye for detail.
• You have a deep knowledge of statistics and have strong analytical skills.
• You are customer oriented and able to influence stakeholders.
• You possess a problem solving hands-on mindset.
• You have excellent priority setting, planning and organizing skills.