Support manufacturing execution system process
- Systech Guardian Masterdata administration (SKU Setup) and process definition
- MES Batch record administration (parameter value list maintenance)
- Liaise with SAP MasterData admin
- Liaise with Engineering Team to gather MES/Guardian and SAP requirements
- Develop and create new MBRs to test new MES/Guardian System Functionality
- Develop testing for new MES and Guardian System Functionality
- Develop and create new MBRs to test new MES/Guardian Serialization Functionality
- Develop testing for new MES and Guardian Serialization Functionality in combination with Amgen’s ERP system
- Provide MES/Guardian support to Testing for Engineering and Validation teams for development and Qualification testing
- Provide MES/Guardian support to Manufacturing Operations
- Participate and engage with MES Manufacturing Operations team in MBR Design
- Participate and engage with MES Manufacturing Operations team in the migration of new System Functionality responsibility from IS to Manufacturing Operations
- Provide training on MES and all its functional aspects to production execution team.
Support primary production process
- Work within full GMP compliance
- Own NCs , CAPAs, CAPA-EVs and Change records
- Perform (comprehensive) NC investigations and CAPA actions
- Perform change assessments for Production area
- Effectively manage CAPA and Change implementation plans
- Ensure timely closure of owned records
- Execute, investigate, determine and implement responses related to audit observations
- Train Production staff on new or revised processes
Improve quality and performance
- Collect relevant production information from other departments
- Assist in the roll-out and implementation of new concepts
- Participate in continuous improvements initiatives
- Participate in / lead assigned internal production projects
- Perform Production risk analyses as part of ABR risk management initiatives
- Become actively involved when required to resolve complex operational issues
- Bachelor degree (relevant education) or the equivalent combination of education and experience
- Minimum 3 years of related experience in an industrial environment
- Experience in a pharmaceutical / GMP environment
- Knowledge and understanding of Good Manufacturing Practices
- Experience in writing procedures
- Fluent in Dutch and English, both in oral and written communication
- Master degree (relevant education)
- Proven implementing skills
- Experience with SAP and Microsoft Excel
- Experience in analysis and reporting techniques
- Experience with Six Sigma / LEAN / Operational Excellence principles
- Insight in qualification / validation approach / strategy
- Knowledgeable about statistical and process control methods.
We will boost your career through personal and technical growth. We’ll support you by offering a personal coach and the possibility to follow courses and training via our highly recommended Yacht Academy. We’ll offer interesting benefits and a market conform salary. You’ll become member of the team of professionals who share your education, ambitions and your competencies. This will enable you to interact with your colleagues from Yacht in your own technology language! You’ll become a member of the yacht network, which stretches the high tech industry. You will be challenged by your peers. As a result you’ll be able to keep your knowledge and skills up-to-date!
Yacht is a contractor for highly educated professionals (BSc, MSc, or PhD) who’ll work on site and innovate together with our customers to find smart solutions. Being part of the world wide Randstad Group we have an extensive network of clients and professionals. Working as a high tech professional within Yacht means you will work on interesting and challenging long term projects for our clients in the Dutch “Brainport” Eindhoven region, mainly on projects at our clients’ Research & Development departments. Our Brainport region is considered to be the smartest region in the world! We cooperate with high tech companies that work on the cutting edge of technology. To give you an example of our portfolio: ASML, Philips Healthcare, Philips Lighting, Philips Research, TNO, FEI company, DAF, VDL ETG, Océ and many others.
Voor meer informatie neem je contact op met Bram Geerets via telefoonnummer +31 0655724609
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.