Title: Metrology Manager
Tempe, Arizona, US
At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
Job Summary:
Responsible for overseeing the day-to-day activities of the Metrology team to maintain the quality of instruments and inspection routines including the maintenance, qualification, and continuous improvement initiatives. Supervise the team to assure compliance with processes and procedures to reduce risks and improve compliance and productivity.
Essential Duties and Responsibilities:
- Maintain and prioritize the metrology schedule through the metrology request system.
- Supervise the day-to-day activities in the Metrology group to maintain the instrument quality which includes:
- Preventative maintenance
- Troubleshooting
- Repairs
- Instrument asset management and life cycle
- Laboratory facilities equipment
- Prioritize continuous improvement initiatives and development of inspection routines including disaster recovery and change control documentation
- Schedule equipment downtime planning with Program Managers and Quality Supervisors to minimize impact to business bottom line
- Assure that direct reports have been adequately trained for their role
- Create strategies to control costs, reduce risks and improve productivity.
- Write and execute IQs, OQs, PQs, and validation protocols for new equipment installation, movement, or software upgrades.
- Review and approve documents such as investigations, work instructions, SOPs, ECRs, risk assessment and deviations
- Collaborate with Operations and Facilities Management to maintain and improve laboratory facility
- Collaborate with vendors/suppliers to ensure instrument needs within Analytical Services are communicated and implemented. Collaborate with Calibration SME to manage calibration requirements for measurement equipment
- Collaborate with Quality to maintain compliance of metrology cleanrooms areas
- Provide support and assistance with equipment, instrument and facilities 24/7 to maintain operations
- Research and recommend new instrumentation to increase compliance and efficiency in Analytical Services
- Maintain metrics for instrument repair history and response time
- Assist and participate in audits
- Provide budgeting information for new instruments, service agreements, etc
- Keep current with new technologies and cGMP regulations.
- Implement continuous improvement/lean activities and events for the group.
- 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.
Preferred Knowledge, Skills and Abilities:
- Education or Equivalent Experience: Bachelor's in Engineering
- General Experience: 8-10 years of experience
- Supervisor experience: At least 2 years of experience
- 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:
- None
Physical & 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.
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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.