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Sr. Metrologist - ManufacturingApply Now Category Quality Control City Plymouth State Minnesota
The Sr. Metrologist - Manufacturing is responsible for the developing and performing calibration procedures to support pharmaceutical manufacturing operations in accordance with all applicable cGxP, FDA and other regulatory requirements. Individuals in this position will also participate in equipment qualification activities and be responsible for determining appropriate calibration points, tolerances, and frequencies.
- Evaluate pharmaceutical manufacturing/packaging equipment and facilities controls and establishes calibration points and associated tolerances.
- Execute routine (annual/semi-annual) calibrations of equipment (Tablet presses, blenders, scales, and temperature, humidity, pressure and flow sensors, etc.
- Provide leadership and training for junior calibration technicians. Independently author SOP deviations and atypical equipment performance investigations.
- Perform equipment troubleshooting activities in support of Manufacturing.
- Coordinate with Manufacturing to identify windows in which calibrations can be performed.
- Document all work performed per GMP requirements with minimal errors.
- Maintain the qualified state of equipment in compliance with USL, FDA and other regulatory requirements.
- Correspond with outside vendors, and other departments with minimal supervision.
- Focus on providing high quality customer service. Prioritize workload independently and tracks completion of high priority activities.
- Manage project timelines and notify management if deadlines will not be met. Propose solutions to reduce the impact.
- Evaluate procedures used for equipment calibration and identify gaps. Propose corrective action to close any gaps.
- Ensure that tasks performed are consistent with Company Policies and Code of Conduct.
Education and experience requirements:
A two-year technical or associates degree in Engineering, Electronics, life sciences, or other technical field OR equivalent military training required. Minimum of 8 years' applicable (metrology, Instrumentation, Calibration) experience, preferably in the pharmaceutical industry. Capable of calibrating manufacturing equipment used to support pharmaceutical manufacturing (Tablet presses, blenders, scales, and temperature, humidity, pressure and flow sensors, etc.). Bachelor's degree (preferred) and 5 years' applicable experience. In lieu of a technical/associates/bachelor's degree, 10+ years' of experience in metrology, instrumentation and/or calibration in a manufacturing environment required.
Other Knowledge and Skills:
Solid understanding of traceability and test accuracy and uncertainty. Solid understanding of instrument, equipment, and loop calibrations of various parameters in manufacturing and facilities. Skilled with pneumatic, mechanical, and electrical instrumentation, including manual and computer based process control loops, and understands the basic concepts of calibration and requirements.
Physical Requirements: Lift / Carry - Waist or Lower (25 lbs. or less): 1 - 33% (Occasional). Listening: 34 - 66% (Frequent). Near acuity (vision): 34 - 66% (Frequent). Sitting: 1 - 33% (Occasional). Speaking: 34 - 66% (Frequent). Standing (Moving About): 34 - 66% (Frequent). Standing (Stationary): 1 - 33% (Occasional). Use of computer keyboard / mouse: 67 - 100% (Constant).Mental and Motor Requirements; Advanced math calculations: 34 - 66% (Frequent). Attention to detail: 67 - 100% (Constant). Ability to prioritize tasks: 34 - 66% (Frequent). Demonstrated ability to follow written procedures: 34 - 66% (Frequent). Independent decision making: 34 - 66% (Frequent). Interaction with others using professionalism and tact: 67 - 100% (Constant). Reading / Comprehension: 34 - 66% (Frequent). Verbal communication: 34 - 66% (Frequent). Writing / Composition: 34 - 66% (Frequent).Environmental RequirementsExposure to active pharmaceutical ingredient: 1 - 33% (Occasional). Exposure to automated machinery: 1 - 33% (Occasional). Exposure to chemicals: 1 - 33% (Occasional). Exposure to pressurized equipment: 1 - 33% (Occasional). Independent Work: 1 - 33% (Occasional). Required to wear safety glasses and other PPE: 34 - 66% (Frequent). Team work: 67 - 100% (Constant). Works in Manufacturing Environment: 34 - 66% (Frequent).
Upsher-Smith Laboratories, LLC. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.
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