Metrology Specialist

Rochester, New York

Unither Pharmaceuticals
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Metrology Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients' lives to as many people as possible. With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees. Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 280 employees. Your role Reporting to the Senior Manager, Engineering, Validation & Metrology, Maintains the calibration group's structure in a compliant manner by writing and implementing calibration and department procedures. Performs and documents calibrations for critical manufacturing and packaging instruments. Provides, implements, and manages continuous improvement projects for the Metrology Department necessary to increase system compliance and efficiencies. Develops and evaluates metrology calibration systems that measure characteristics of objects, substances, or phenomena, such as length, mass, time, temperature, electric current, and speed. Develops calibration methods and techniques based on principles of measurement science, technical analysis of measurement problems and accuracy and precision requirements. ESSENTIAL FUNCTIONS / RESPONSIBILITIES: Calibrated Instruments (40%) Schedules Calibrations with Mfg., Pkg. and other internal customers using calibration software. Performs calibrations on critical manufacturing, environmental, and packaging instruments. Performs hands on Calibrations on in-house equipment. (Using calibration software, calibration instruments, calibration Standards, hand tools, ladders, and power moving equipment. Supervises manufacturing personnel when there help is needed. Reviews and signs other calibration documentation. Process Improvements (40%) Utilizes understanding of regulatory environment and industry trends to identify ways to improve process quality and compliance. Ensures stakeholders are appropriately trained on the process and any process changes. Provides project leadership for, or assists in the completion of, improvement projects or the purchase of new instruments. Calibration SOP's (20%) Writes and maintains standard operating procedures for critical instruments. Writes and implements calibration department procedures necessary to maintain cGMP and company requirements. Updates, maintains, and queries computer database for critical instruments. Calibration Application Available, Accessible, and Functions According to Intended Use and Compliance Requirements (20%) Creates and maintains application procedures and system configuration documents. Manages application validation and change control activities. Proactively utilizes data to prevent occurrences that may impact application systems availability, function and/or performance. Manages application Refresh/Upgrade lifecycle activities Administers application security, bug and functional enhancement patches. Ensures applications meet business and user requirements KNOWLEDGE SKILLS & ABILITIES: Proficient in the ability to perform instrument adjustments, repairs and programming Identify system needs and create solutions. Understanding of electronics and their use in calibrating instruments. Understanding and communicating industry applications for new instrumentation needs. Proficient in the following types of instrument calibrations:temperature, humidity, weight, flow, speed, conductivity, and pressure. Understanding and communicating industry applications for new instrumentation needs. Ability to perform mathematical calculations necessary to identify calibration parameters. SCOPE OF DECISION-MAKING: Decisions require basic/routine analytical judgment. Plan and perform diversified duties requiring knowledge of a particular field and the use of a wide range of procedures. Involves the exercise of judgment in the analysis of facts or conditions regarding individual problems or transactions to determine what action should be taken within the guidelines or standard practice. LEVEL OF SUPERVISION PROVIDED: Project direction of other employees performing the same or directly related work, including assigning, reviewing, checking work, eliminating ordinary supervisory/management positions. INTERNAL / EXTERNAL CONTACTS: Regular inside and outside the organization: Requires regular contact with subordinates and/or other departments, with occasional contacts with individuals outside the organization. Also includes jobs with regular customer/client contacts. PHYSICAL REQUIREMENTS/ENVIRONMENT: Climb ladders, standing/walking 30% of time, sitting 70 % of time. Moderate lifting required. Controlled environment with a moderate amount of noise. Must wear personal protective equipment. Currently scheduled for five, 8-hour days assigned to "A" shift. Must be able to work overtime as needed. Your profile Associates' degree in Engineering, Electronics, Instrumentation or related field 5+ years' work experience in instrument calibrations. Experience with Blue Mountain Calibration Manager software, and Crystal Reports software a plus. Compensation range 65,000.00 - 70,000.00 USD The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations. Learn more about us: We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees. Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives. We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential. We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility. Join us and make a difference.
Date Posted: 18 April 2024
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