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.

• 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

• 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

• 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

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