Mylan Technologies Inc.
Senior Specialist, Calibration
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world’s largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information, please visit
Support routine validation, calibration, maintenance, and repair of laboratory instrumentation involved in the testing and inspection of components, intermediates and finished products. Calibrate and maintain tools, instruments and equipment used throughout the plant. Assist the Calibration Manager in coordinating the day to day activities of the group.
Performs job functions in accordance with the Occupational Safety and Health Administration (OSHA) guidelines. Ensures compliance with Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations and Current Good Manufacturing Practices (cGMPs).
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Execute validation, calibration, maintenance, and repair of GCs, HPLCs, electrical meters, line speed, footage meters, all process equipment, and other instruments included in Mylan Technologies, Inc. calibration program.
Assist laboratory staff with the identification and purchase of new analytical equipment as required.
Work with external and interal customers in the creation and modification of protocols, calibrations, procedures, schedules, and documentation for instruments in the laboratory and production as required.
Work with Q/A, manufacturing, and labatories in the investigation, documentation, and corrective action of events involving labatory instrumentation.
Manage the stock of spare parts and consumables required to meet validation, calibration, and maintenance of GC, HPLCs, and other instruments to meet schedules.
Assist the Calibration Manager in coordinating the day to day activities of the group through assuring schedule attainment, reporting, etc.
Make recommendations and/or corrective actions when equipment fails to meet calibration criteria.
Maintain schedules and records for all equipment which is calibrated.
Clean up equipment and work area after performing maintenance functions.
Perform maintenance, repair, and installation including IQ, OQ, and PQ of instrumentation used within MTI
Manage outside contractors and vendors
May act as a backup to the Calibration Manager as required.
Perform other duties as assigned.
Must possess knowledge of Various laboratory instrumentation including; dissolution baths, HPLC’s, GC’s, FTIR, UV-Vis Spectrophotometers, Instron, balances, pH meter, etc. Knowledge of scientific software, basic word processing, and spreadsheets. Must possess knowledge of power hand tools, hand tools, and test instruments for calibration. Must be experienced in the calibration of various instrumentation such as temperature, pressure, flow, etc. Must possess knowledge of plant machinery and equipment. Must possess knowledge of personal computers, word processing, spreadsheets and calibration software.
Must adhere to Company and Department policies and procedures as well as government regulations. Requires understanding of Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations and Current Good Manufacturing Practices (cGMPs).
SKILLS AND ABILITIES
Must possess strong basic math skills, ability to communicate (written and verbal). Must have experience in development of methods for HPLC and GC, plus familiarity with laboratory automation equipment.
Minimum of a Bachelor's degree and 2-4 years of experience as a chemist or equivalent working in a laboratory environment. However, a combination of experience and/or education will be taken into consideration.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Occasional lifting of up to 50 pounds. Limited use of a respirator.
May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms.
At Mylan, we are not satisfied with anything less than being the best. As one of the world's leading generics and specialty pharmaceutical companies, the key to our success starts with a relentless drive to set the highest industry standards in everything we do. It takes exceptional people working together to achieve excellence. As a team, we earn our customers’ trust and loyalty by placing a high premium on always doing the right things in the right way.
Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. Mylan is an Equal Opportunity Employer, M/F/D/V.
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