Title:  Principal Engineer, Quality Automation & Inspection

Job Summary

• This role will drive technical transformation within manufacturing and quality operations by implementing automated inspection processes within Quality Assurance.
• This role is key to implementing new technology, developing and introducing process improvements, managing equipment life cycle, and executing validation.
• This person 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, this person 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 & 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 & 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 analysis to identify short 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, instruction, and all safety rules.

Education

• BS degree preferably in a technical discipline such as engineering or equivalent experience required

Work Experience

• Minimum 5 years of experience in technical or engineering field.
• Must have a 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

Preferred Knowledge, Skills and Abilities

• 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 & SPC tools and techniques
• Experience with ISO 9000 standards and GMPs.
• ASQ certification 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

License and Certifications

• Engineering - General\ASQ Certified Quality Engineer (CQE or CQA) Upon Hire preferred and
• Manufacturing\Six Sigma Green Belt Certification Upon Hire preferred or
• Manufacturing\Lean Six Sigma Black Belt Upon Hire preferred

Travel Requirements

Physical Requirements

Additional Requirements

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations
• Maintain high attention to detail, accuracy, and overall quality of work
• Must be able to multi-task, work under time constraints, problem solve, 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