Principal Engineer Quality Automation & Inspection
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Principal Engineer Quality Automation & Inspection
West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2020 sales of $2.14 billion reflect the daily use of approximately 112 million of its components and devices which are designed to improve the delivery of healthcare to patients around the world.
Location: Eschweiler, North Rhine-Westphalia, DE Department: Quality Job summary
You will drive technical transformation within manufacturing and quality operations by implementing automated inspection processes within quality assurance.
You are key to implementing new technology, developing and introducing process improvements, managing equipment life cycle, and executing validation.
You will provide the company with the technical and quality resources to manage deliverables focused on metrology for elastomer and primary containment pharmaceutical products.
With a global mandate and scope, you will have the opportunity to drive the implementation of innovative processes and technologies in cooperation with the engineering, operations, IT, and quality assurance teams and the plants.
Essential duties and responsibilities
Lead the identification, testing, design, and development of innovative automation solutions to measure product dimensions and inspect for defects
Lead the move to integrate inspection equipment into automated production lines
Scale developed solutions to production
Initiate, lead, and coordinate improvements and lean waste reduction of existing processes
Work with site SMEs to validate solutions, including the preparation of validation documentation, execution of validation protocols, and triaging of unexpected events
Ensure that procedures and systems are in place to introduce new processes and equipment
Support training and development of personnel on new processes and systems
Harmonize best practices by assessing current process status in all relevant West locations globally, defining best practices, performing gap analyses, and managing the harmonization
Interface with customers and suppliers on new and existing inspection and quality projects
Support global data integrity alignment projects for inspection equipment
Work with interdisciplinary teams to perform root cause analysis and implement corrective and preventive actions
Conduct data trend analyses to identify short-range and long-range patterns to support continuous improvement initiatives.
Participate in budgeting and business planning activities
Prepare data / presentations and attend quality review meetings with senior leadership
Ensure compliance with cGMPs, FDA and other regulations as necessary
Abide by all regulations, policies, work procedures, instructions, and all safety rules
Qualifications
Bachelor's degree, preferably in a technical discipline such as engineering or equivalent experience required
Several years of experience in technical or engineering field
Very good knowledge of manufacturing automation and the development of quality plans for high-speed manufacturing
Knowledge of machine control systems and integrated manufacturing control
Excellent interpersonal skills: good team player and individual contributor as well
Strong problem-solving and critical thinking skills to troubleshoot issues and identify root causes
Experience in automation industry
Knowledge of ISO / ASME GD&T requirements, interpreting 2D engineering drawings and 3D models
Proven experience of statistical methods (Measurement System Analysis (MSA), equivalence, design of experiments)
Experience using Six Sigma and SPC tools and techniques
Experience with ISO 9000 standards and GMPs
ASQ certification is highly desired
Green Belt or Black Belt certification
Graduate degree (MS)
Knowledge of AI-based vision tools and deep learning defect detections
Experience with AI/ML-based vision systems
Able to be aware of all relevant SOPs as per company policy as they are related to the position covered by this job description
Engineering – General \ ASQ Certified Quality Engineer (CQE or CQA) Upon Hire preferred
Manufacturing / Six Sigma Green Belt Certification Upon Hire preferred
Manufacturing / Lean Six Sigma Black Belt Upon Hire preferred
Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events
Ability to work well with others in a variety of situations
High attention to detail, accuracy, and overall quality of work
Ability to multi-task, work under time constraints, solve problems, and prioritize
Ability to make independent and sound judgments
Observe and interpret situations, analyze and solve problems
Effectively communicate and interface with various levels internally and with customers
Physical requirements: light exerting up to 20lbs / 9kg of force frequently and / or negligible amount of force frequently / constantly to move objects
Travel requirements: 20%: up to 52 business days per year
What sets us apart?
Internationality – As an American company, we live a global cooperation within international structures
Philanthropy – We value an appreciative and friendly work environment as well as flat hierarchies
Market-appropriate remuneration – We offer an attractive, market-oriented remuneration, including company social benefits and purchasing 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 benefit from an extensive range of trainings as well as from a constant and targeted employee development
Family-friendly culture – We attach great importance to reconciling private life and work; flexible working hours are definitely a matter for us
Have we aroused your interest?
Then become part of our West family! Please apply online with your complete application documents in English via our recruiting system ! We are looking forward to meeting you!
West Pharmaceutical Services Deutschland GmbH & Co. KG Kiefernweg 5, 52249 Eschweiler, Tel.: +49 2403 796-0 West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies is contingent upon the satisfactory completion of post-offer background screening and/or drug screening. www.westpharma.com