SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Pharmaceutical organization, based in Noord-Brabant Netherlands.
You will work within a GMP regulated environment.
As MES Specialist you provide operational support the Werum PAS|X|MES environment with knowledge on admin and Functional MBR Editing in a GMP (Good Manufacturing Practices) regulated atmosphere. You are responsible as a system owner for deploying software, incident management, problem management, life-cycle management, system maintenance including application upgrades, projects, enhancements and security patches. Your proven overall IT and automation integration knowledge, communication skills experience will enable you to liaise effectively with clients, users and IT experts (application, network, database, etc.) locally as well as with other Amgen sites worldwide in order to provide IT solutions for clients. You have the discipline and technical knowledge to work independently and take on responsibilities. You Design and deploy new innovative solutions to improve the efficiency of our application environment. You ensure procedures are followed and new systems are implemented in compliance with FDA/EMA and other regulatory requirements. You work with other IT and engineering experts, vendors and customers to ensure regulatory (e.g. validation), business, functional and application specific requirements are met.
- Thorough knowledge of Werum PAS X| MES.
- Technical Admin support on PAS|X, and functional GMBR Editing knowledge
- Ensure as system owner that all GMP related activities are done right and on time.
- Accountable for second line support of MES and serialization.
- Participate in the on call process.
- Knowledgeable regarding FDA GxP and 21 CFR regulations and understand software system validation.
- Demonstrates knowledge about IT and Engineering processes.
- Attends and/or facilitates cross-functional team meetings to develop and implement business solutions and optimize operations.
- Translates requirements into technical solutions that meet business needs.
- Promotes and develops communication between the business, technical staff and suppliers to integrate cross functional Amgen business needs.
- Participating in projects as a system owner.
- Creates, Reviews and approves project documentation.
- Maintains knowledge of IS quality and compliance policies, SOPs and associated documents.
- Support, participates in and responds to questions and findings from regulatory and other audits.
- Bachelor degree in Information systems, Computer Science or Life Sciences.
- 5 years of Information Systems (IS) experience preferable within the pharmaceutical or biotech industry.
- 5 years of experience with installing, testing and deploying new IT solutions in an Engineering environment.
- Experience in PAS|X and automation integration.
- Knowledge of ITIL fundamentals in Service operations and Application life cycle processes.
- Knowledge of change management and validation of computerized systems (e.g. GAMP5).
- Fluent in English (both verbal and written).
- Excellent organization skills, detail oriented and accurate.
- Skilled in working under pressure, must possess good time management skills.
- Able to communicate ideas in both technical and use-friendly language.
- Experience in developing and executing SOPs, Installation and Operational (IQ, OQ) Protocols.
- Experience in working with solution lifecycle methodologies e.g. Agile and RUP.
- Ability to work in global, cross-functional and virtual teams in different time zones (flexibility in work hrs.).
- Experience with Systech Serialization suite.
- Industry Standard Technical Certifications a plus : A+ Certification
- Strong customer service skills, ability to work in teams, excellent verbal and written communication
- Ability to understand and challenge business processes, requirements and proposed solutions to help define strategic, robust, and scalable solutions