Senior Quality Automation Engineer (m/f/d) in der Städteregion Aachen
West Pharmaceutical Services Deutschland GmbH &Co. KG - Vollzeitbeschäftigung
Start ab sofort - Online seit dem 06.10.2020
Welcome to West!
Established in 1923, West Pharmaceutical Services, Inc. has become a global leader in innovative solutions for injectable drug administration. Eachevery day, West manufactures more than 112 million products that are used to help improve health care for millions of people around the world.
our team of 7,500 employees in 16 countries to help us write the next chapter of our success story. We are constantly looking for new talentspeople who won’t settle for second best. Thinkers. Doers. Enthusiasts. As an employee, you will experience a collaborativedynamic global working environment,your development is our priority.
Make a difference as a Senior Quality Automation Engineer (m/f/d)
As a Senior Quality Automation Engineer (m/f/d), you will be leading the West automation quality validation program globally. Within our QA Team you will help to drive the roadmap to continually improve our quality processesactivities by focusing on automated forming cell for rubber pharmaceutical devices.
You will be the quality support in the preparation, reviewingapproving of VMP, URS, FAT, SAT, IQ, OQ, PQother relevant documents, reportsprotocols associated with the automation validation lifecycle at West
You will facilitate equipmentprocess FMEAensure in collaboration with the Program Manager that the SMEs are trainedupdated on the FMEA process
You will provide input to the developmentlead the implementation of the control strategy for the automated process
In addition, you will review that the proceduressystems are in placeensure compliance with FDA, GMPother regulations
You will participate in the reviewdisposition of all quality attributevariable data for the program against West specificationdrawing e.g. Ppk's, Cpk's, FAT visual inspections
You will draft the defect library during validation with formal hand over to Operational Quality prior to PQ
You will also be involved in the leadingparticipation of several continuous improvement projects associated with quality enhancementsoperational lead initiative
To drive improvements of sampling data, project protocolsreports, you will be expected to trendtrack validation data
You will support the close-out of change control, deviations, quality continuous improvements identified during the project
You will lead investigationsmaterialproduct issues to ensure a thorough root cause, containment / correctivepreventive action is implemented,learnings are takenOperations
At all levels within West you will support trainingdevelopment of personnel on new processessystems
In our GMP environment you will support productprocess transfer projects as well as newexperimental development activitiesplants
In order to succeed in this position, you will need a bachelor’s level degree in Engineering, QualitySciences
You have minimum 5 years of professional work experience within the manufacturing industry with an expertise in manufacturing automation, machine designprocess validation
You have a proven track record of machine control systemsintegrated manufacturing control systems. A deep understanding of GAMP 5 guidelinescGMP would be an asset
Ideally, you will bring good knowledge of LEANSix Sigma manufacturing principles as well as working knowledge of Statistical Process ControlsMinitab Software
To find your way in a dynamic environment, you are able to assert technical solutionsstandards
On a personal level, you will be a good team playerindividual contributor with a self-motivated, results-solution-oriented attitude
As you will interact at all levels, you will bring excellent writtenverbal skills in English
Internationality – As an American company, we live a global cooperation within international structures
Philanthropy – We value an appreciativefriendly work environment as well as flat hierarchies
Market-appropriate remuneration – We offer an attractive, market-oriented remuneration, including company social benefitspurchasing benefits
Social engagement – We support local aid organizations through various actions organized by our employees
Diversity – We at West value the wide range of our employees who make up our company
Safety – Occupational safety is our highest priority; we offer secure jobs in a sustainable industry
Development opportunities – Our employees benefitan extensive range of trainings as well asa constanttargeted employee development
Family-friendly culture – We attach great importance to reconciling private lifework; flexible working hours are a matter of course for us
Bitte geben Sie bei Ihrer Bewerbung die Referenznummer acjobs-st-62914an.