West Pharma Calibration Engineer 

United States, Arizona, Scottsdale 

903935173

Job Summary:

Driving Process Improvements and Developing Calibration Capabilities. Will be responsible for identifying and implementing process improvements in the calibration function. This includes developing new calibration methodologies to improve the calibration process and ensuring that all instruments, gauges, and other testing and measuring equipment are set up, checked, and maintained to ensure they continue to give accurate, precise, and reliable results. Maintain a safe work environment and ensure compliance with quality objectives and policies. Work with business leads to develop, implement, and maintain programs and enhance solutions for customer base. Knowledge of calibration and mechanical inspection. Possess excellent oral and written communication skills; displays good documentation practices. Experience with quality software and inspections. Provide knowledge on the set up and operation of calibration equipment and assist in technical guidance and fault diagnosis. Write calibration requirements/specification to support validation activities in line with business needs. Lead and/or participate in continual improvement projects.

Essential Duties and Responsibilities:

• Collaborating with Calibration Technicians. Will work closely with calibration technicians to ensure accurate and timely calibrations. This includes providing guidance and training, sometimes on-site, for calibration processes and development experiments.

• Coordinating with External Labs. Will coordinate with third-party labs to expedite equipment calibration. This includes maintaining accurate records of accreditations held by external labs and ensuring they comply with the ISO 17025 standards.

• Assisting in Specifying Equipment. Will assist in specifying equipment for consistent measurement uncertainty. This includes understanding traceability, substitution of standards, test accuracy, and uncertainty ratios as part of ISO 17025 requirements.

• Selecting Appropriate IM&TE for Calibration Standards. Will be responsible for selecting the appropriate Inspection, Measuring, and Test Equipment (IM&TE) for calibration standards. This includes understanding and applying basic concepts of calibration and requirements including accuracy testing.

• Developing and Maintaining Written Calibration Procedures. Will develop and maintain written calibration procedures to ensure consistency and accuracy in the calibration process.

• Ensuring IM&TE Equipment is Capable and Properly Preserved. Will ensure that all IM&TE equipment can perform its intended measurements and is properly preserved to maintain its integrity and accuracy.

• Maintaining Suitable Environmental Conditions for Calibrations. Will maintain suitable environmental conditions for calibrations to ensure the accuracy and reliability of calibration results.

• Keeping Records of IM&TE Calibrations and Reporting Discrepancies. Will maintain accurate calibration records and report any discrepancies or issues discovered related to calibration to the appropriate parties.

• Safeguarding IM&TE from Adjustments that Invalidate Calibration Settings. Will safeguard IM&TE from adjustments that could invalidate calibration settings, ensuring the reliability and accuracy of all measurements.

• Lead, develop and support calibration methods in compliance with quality regulations (ISO 9001, ISO 13485, 21 CFR Part 820 GMPs)

• Cleanroom sustaining for calibrated equipment.

• Administration of equipment calibration and program maintenance.

• Performs other duties as assigned based on business needs.

• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

• Exhibits regular, reliable, punctual and predictable attendance.

• Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste.

• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.

• Maintains a clean, orderly and safe workstation and environment at all times.

• Conforms with and abides by all regulations, policies, work procedures, instruction, and safety rules.

• Exhibits regular, reliable, punctual and predictable attendance.

• Performs other duties as assigned based on business needs.

Basic Qualifications:

• Education or Equivalent Experience: Mechanical Engineering or similar
• Experience: 5-8 years of experience.

Preferred Knowledge, Skills and Abilities:

• Basic understanding of CAD packages.
• Experience programming one or more of these OGP, Micro-Vu, or PCDIMIS measurement systems.
• GR&R.
• Computer Skills.
• Proficiency reading blueprints.
• Ability to meet deadlines.
• Excellent communication ability.
• Strong problem-solving skills.
• Strong understanding of Geometric Dimensioning and Tolerancing (GD&T).
• Demonstrate understanding of QC and/or Six Sigma skills such as Control, Run, and Pareto Charts, Histogram, Scatter Plot, Gantt chart, Fishbone Analysis and Process Capability.

Travel Requirements:

Physical and Mental Requirements:

• Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
• May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear audible alarms from distances up to 150ft.
• The ability to be able to lift and carry various items up to 50lbs.