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Title:  Principal Engineer QA, Automation Validation (m/f/d)

Requisition ID:  43504
Date:  Jan 2, 2022
Location: 

Eschweiler, North Rhine-Westphalia, DE

Department:  Quality
Description: 

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

 

West in Germany has received a local Best Jobs award in 2020 and 2021 and is now listed in the top 700 employers that offer a safe job with a great perspective for the future. 

 

 

 

Location: Kiefernweg Campus, Eschweiler, NRW

Contract details: Permanent, Full-Time

Travel requirements: up to 20 %

Start date: asap

Contact person: Martina Erens

 

 

Job Summary:

As a Principal Engineer, QA, Automation Validation (m/f/d), you will be leading the West automation quality validation program globally. As part of a wider Team, you will be responsible for the quality deliverables on the development and deployment of automated forming cell for rubber pharmaceutical devices.

 

 

Essential Duties and Responsibilities:

  • You will be the quality support in the preparation, reviewing and approving of VMP, URS, FAT, SAT, IQ, OQ, PQ and other relevant documents, reports and protocols associated with the automation validation lifecycle at West
  • You will lead the development and implementation of the control strategy for the automated process
  • In addition, you will review that the procedures and systems are in place and ensure compliance with GMP and other regulations
  • You will participate in the review and disposition of all quality attribute and variable data for the program against West specification and drawing
  • You will also be involved in the leading or participation of several continuous improvement projects associated with quality enhancements and operational lead initiative
  • You will drive the close out of change control, deviations, quality continuous improvements identified during the development and deployment projects
  • At all levels within West, you will support training and development of personnel on new processes and systems

 

Your Profile:

  • In order to succeed in this position, you will need a bachelor’s degree in Engineering, Quality or Sciences
  • You have at least 5 years of professional work experience within a high-speed manufacturing industry with an expertise in manufacturing automation and validation process
  • A comprehensive Quality Management education is essential
  • Ideally, you will bring good knowledge of LEAN and Six Sigma manufacturing principles as well as working knowledge of Statistical Process Controls and Minitab Software
  • The understanding of GAMP 5 guidelines would be helpful
  • To find you way in a dynamic environment, you are able to assert technical solutions and standards
  • On a personal level, you will be a good team player and individual contributor with a self-motivated, results- and solution-oriented attitude
  • As you will interact at all levels, you will bring excellent written and verbal skills in English. A working knowledge in German is advantageous

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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