Metrology Manager

West Pharmaceutical Services•Scottsdale, AZ

43d•Onsite

About The Position

In this onsite role, you will be responsible for all metrology related activities, you will also be key to implementing new technology, developing, and introducing metrology process improvements, standards, life cycle management and validation in metrology process areas, helping to advance and transform West's growing business, supporting capital investments, and contributing to addressing complex assignments. With a global mandate and scope, this person has decision rights for his/her process area, and he/she will have the opportunity to drive the implementation of new innovative processes and technologies in cooperation with the engineering and quality assurance teams and the plants. The Global SME is a member of the West Global Engineering Team and will report directly to the Global Metrology Manager.

Requirements

Bachelor's Degree In engineering /manufacturing or another scientific area required
Minimum 8 years experience in a similar position within the manufacturing or regulated industry required
Good knowledge of LEAN and 6 sigma manufacturing principles
cGMP knowledge .
High level of interpersonal skills, organizational skills, and analytical skills.
Demonstrated ability to influence without direct authority.
Work autonomously in a virtual environment, managing multiple priorities with a sense of urgency.
Demonstrated ability to exercise independent and sound judgment in making decisions and resolving complex challenges. Make decisions with in-depth understanding and interpretation of procedures, policies, and business practices to achieve results.
Proficient knowledge of ISO/ASME GDigital and Transformation requirements, interpreting 2D engineering drawings and 3D models for various levels of medical device components, assemblies, and subassemblies using CAD system (e.g., SolidWorks).
Knowledge of programming coordinate measuring machines is essential using software like: PC-DMIS, Calypso, Volume Graphics.
Knowledge and experience with in-house calibration procedures and calibration management software including day to day inspections of equipment.
Working knowledge of ISO 9001:2000 / ISO 13485.
Knowledge of generating validation documentation and subsequent reporting
Knowledge of generating Standard Operating Procedures and Work Instructions
Knowledge on Instron, CMM and OGP equipment and other measurement/inspection 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
Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
Able to always comply with the company's safety policy.
Experience with change management and process implementation
Proven experience of Measurement System Analysis (MSA) development, Minitab and statistical packages is essential. (i.e., Measurlink)
Must possess good communication/interpersonal skills; must be detail orientated, organized, flexible and be able to handle multiple tasks and time critical projects/deadlines.
Strong problem solving and critical thinking skills to troubleshoot issues and identify root causes.
Computer literacy required including all Microsoft Office utilities.
Ability to successfully utilize influence to motivate a team toward a common goal.
Drives a culture of continuous improvement and lean operations.
Ability to assert technical solutions and standards in an international environment.
Excellent communication skills and ability to successfully collaborate with teams across different countries and organizational levels.
Highly analytical and structured way of working
Self-motivated, results- and solution-oriented personality.

Nice To Haves

Minimum 3-5 years leadership experience preferred
CT scanning knowledge would be a distinct advantage.
Training/certification in dimensional measurement (i.e., NPL, AUKOM). Upon Hire preferred.

Responsibilities

The SME process area of focus is Metrology Systems.
Manages Metrology team, engineers and technicians to support metrology activities in a proper and timely manner.
Ensures departmental KPIs metrics are in place to ensure proper monitoring and continuous process are in place.
Establishes a Goals and Objectives set for the team members and a development plan.
Initiate, lead, and coordinate continuous process improvement projects for existing metrology systems using the knowledge and best practices, even if this is outside the standard known/approved process frame.
Manage Procurement, validation, set-up and maintaining metrology and measurement systems/equipment
Manages Validation process/strategy, set-up and maintaining for new equipment introduced to Metrology lab.
Prepare and obtain approval for project time schedules and ensure conformance to such plans and to the related budgets in implementation.
Initiate and maintain appropriate communication with customers, facilities, and departments to support good relations and maximise achievements through a cooperative environment on large/multi-site projects.
Support the assessment of current Metrology process status in all relevant West locations, define best practices, perform a gap analysis, and manage the harmonization of this best practice to all sites involved.
Document and review metrology system validation via protocols and reports using West procedures.
Manages the calibration program for site equipment by ensures that all metrology equipment is correctly calibrated through auditing, managing, and scheduling the calibration of inspection equipment through external vendors.
Demonstrate advanced knowledge of specific processes to support the Global Operations organisation, as part of the Global SME network.
Manage product, systems process, or technology transfer projects between plants from a metrology standpoint as assigned and including, but not confined to, supporting at a site level.
Creates,evaluate and approve all change requests related to the area of expertise.
Engage in solutioning product or process related issues as needed.
Ensure that all projects and activities comply with local, regional, and best practice requirements on HSE and meet other applicable authority requirements. All internal change control procedures incl. e.g. adequate risk assessments are to be followed strictly.
Support workstreams to implement / roll-out new innovative processes and technologies in cooperation with the engineering- and QA team and the plants from a Metrology point of view.
Ensures departmental KPIs metrics are in place to ensure proper monitoring and continuous process are in place.
Actively participate in the updating, sharing and maintenance of a system to gather metrology related knowledge (Knowledge management)
Contributes with a continuous improvement mindset to deliver cost saving projects that improve current internal process
Coordinate/interface between Research and Development and shop-floor production for new products introduction.
Other duties as assigned.