Metrology Technician

POLICY

The Metrology Technician shall be familiar with the requirements of the job description, the McGuff organizational chart, and disciplinary procedures.

PROCEDURE

I. Job Description:

The Metrology Technician will demonstrate the skills and knowledge of a Metrology Technician while administering the Calibration system, performing Calibration activities, and planning/scheduling external calibration service providers for all calibrations.  

Duties shall include:

1. Maintain a verifiable metric of > 99.5% timely calibration of active gages/ instruments under calibration control for two pharmaceutical manufacturing facilities.

2. Develop, implement and conduct in-house calibration procedures and tasks to improve internal calibration procedures and shorten calibration timelines. 

3. Manage Metrology daily calibration operations

4. Ensure complete, accurate and timely documentation of all calibration activities.

5. Review and approve calibration reports, verify, investigate and address out of tolerance conditions.

6. Oversee calibration work performed by other personnel and or external service providers to ensure proper execution.

7. Understand and perform calibrations on, for example, Temperature, Pressure, Conductivity, UV, Balances, Scales, Vacuum, pH, CL2, ORP, Timers, RPM, Liquid/Gas Flow, and Gas detector instrumentation, etc. 

8. Understand and interact with Automated Control Systems and control system instrumentation concepts, and the relationship between each other.

9. Understand and implement Gage Repeatability & Reproducibility (Gage R&R) science and apply Measurement System Analysis (MSA) topics, techniques and tools.  

10. Understand the operation, maintenance, modifications, and troubleshooting of manufacturing and test equipment (e.g. Steam sterilizers (Autoclaves), Depyrogenation Ovens/Tunnels and Isolators).

11. Initiate corrective action to ensure potentially hazardous situations are avoided and safety standards are maintained relative to production or facilities.

12. Prepare and maintain accurate records and reports per Standard Operating Procedures.

13. Negotiate timelines/schedules for performance of calibration, repair or PM work through collaboration, coordination and cooperation with production, laboratory and engineering/facilities leadership.

14. Read/interpret the production schedule to optimize calibration compliance within production constraints.

15. Optimize calibration resource allocation.

16. Coordinate workload/workflow to determine calibration resource needs on a daily basis.

17. Other varied duties as assigned by his/her immediate manager.

II. Physical Requirements:

Must be able to lift and carry up to 75lbs. In general, the position requires a combination of sedentary work and walking around observing conditions in the facility. Must be able to work in controlled environments requiring special gowning. The employee must bend, squat, climb, reach above shoulder level, sit, stand, walk, handle objects (manual dexterity), and use the finger movement.

III. Qualifications include:

1. Education: Minimum of High school diploma or equivalent, 2 year technical degree preferred. 2 year technical/AA/AS degree in metrology, instrumentation, electronics, or related technical discipline. Skilled craft training/apprenticeship certificate or commensurate combination of technical education and experience.

2. Minimum of 3 years relevant industry experience in Process Instrumentation/ Calibration. 

3. Prefer minimum of 3 years of experience in a cGMP pharmaceutical manufacturing environment or equivalent regulated industry.

4. Prefer working knowledge of NIST, FDA cGMP requirements and/or working knowledge of ISO 9000 requirements. 

5. Computer literate and familiar with 

a. MS Office Applications, Word, Excel, Visio, Project, Access.

b. MasterControl EDC system

IV. Expectations:

1. Comply with all McGuff Policies and Procedures.

2. Comply with gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the controlled manufacturing environment.  

3. Able to work in a cold and/or wet environment.  

4. Able to work multiple shifts, including weekends, as required.  

5. Able to work overtime as required.

6. Appropriate professional demeanor.

7. Knowledge, understanding and compliance of the dress code and corporate policies.

8. Ability to work with others.

9. Excellent communication skills.

10. Work with all McGuff employees to foster and promote quality and customer satisfaction throughout both organizations.

11. Excellent customer relations, communication, negotiation and conflict resolution skills