Primary Duties:

Responsible for planning tests, performing them, and evaluating the results.Reports findings, opinions and interpretations to management.Responsible for the modification of measurement methods, development, and validation of new methods.Responsible for standards, test equipment, and maintenance of equipment monitoring programs.Performs type evaluation examinations.Provides technical guidance to Metrology Staff as required.Able to perform additional duties as requested by management.

Responsibilities: 

40%

Taking care of primary and secondary working standards and assuring their safekeeping.Performing periodic maintenance of primary and secondary working standards including cleaning and minor adjustments as needed.Performing standards inter-comparison.Arranging for outside vendor calibrations as needed.

25%

Selecting check standards and/or equipment for use in monitoring programs.Performing repeated measurements using the check standards or equipment to collect data and control charts as needed.Constructing control charts for the appropriate type of evaluation tests used in the laboratory.Evaluating control limits and comparing new data points to those control limits to monitor laboratory output.Documenting, investigating, and correcting any out-of-control conditions.Evaluating the potential impact on clients that may be affected by the conditions.

 25%

Scheduling the workload of the laboratory standards. Selecting and performing the appropriate tests on devices while following procedures.Documenting the tests through test worksheets and preparing formal conformance reports.Ensuring that all paperwork is correct and ensuring that copies are safely maintained.Developing standard inter-comparison programs and schedules.

10%

Corresponding with clients regarding the capabilities, schedules, and requirements of the laboratories.Answering questions regarding metrology, specifications, tolerances of standards, measuring equipment, and other related activities.Corresponding with vendors regarding standards calibrations, documentation interpretation, and other related activities.

Education and Experience Requirements:

Expertise in calibration field and familiar with ITS-90, ISO17025 and Z540 Standards.Bachelor or Associate Engineering Degree in Mechanical or Electrical field preferred, plus five years experience in Metrology Laboratory with two years in a Primary Standard Calibration Program, or ten years’ experience in Metrology Laboratory with two years’ experience in a Primary Standard Calibration Program.Desired completion of Resistance Thermometry Calibration training program.

Key Skills, Abilities, and Competencies:

Strong communication and presentation skills.Self-motivated and capable of working with general directions.Ability to present ideas persuasively and achieve a consensus.Able to solve problems and make decisions to obtain desirable results.Have extensive knowledge related to the instrumentation, equipment, and the procedures used in a pharmaceutical cGMP environment.

Complexity and Problem Solving:

Works on problems in which analysis of data requires in-depth evaluation of various factors.Exercises judgment in selection of the methods, techniques, and evaluation of criteria to obtain desirable results.Develops improvement in standard operating procedures, and contributes to the development of measurement techniques and standards selection.Considered a Subject Matter Expert in the field within the organization.

Internal and External Contacts:

Delivers requested information as needed throughout the organization and reports the results.Works with vendors and consultants to support related activity.Represents the interests of the organization in external or internal dealings.

Other Job Requirements:

The ability to work at all Takeda site locations/facilities.Incumbent will be required to carry a phone and be on call as required to support operations.Incumbent should be able to climb a ladder, reach, bend, and lift loads up to 50 lbs.