Metrology Specialist

Sagent Pharmaceuticals

Metrology Specialist

Sagent Pharmaceuticals, founded in 2006, was built to focus on customer needs. At Sagent, we believe that excellence is our standard, our motivation and our guide. We believe the measure of success is determined by our customers, as we are a customer-focused company, delivering an extensive portfolio of injectable products and fulfilling the evolving needs of the patients we serve through our unique network of global resources.

The Metrology Specialist will improve & support the safe & effective completion of calibrations. They will support troubleshooting, problem solving & project implementation for measuring equipment site-wide and ensure compliance with cGMPs as well as local & corporate requirements for calibration compliance.

Candidate Accountabilities:

Advanced Metrology Accountabilities

• Leads, conducts & participates in systematic problem solving. Supports cross-functional investigations in all customer areas
• Evaluates measuring equipment performance & effectiveness of tasks & frequencies. Responds to potential issues
• Provides coaching & support to metrology technicians & process owners for measuring equipment.
• Accurately performs complex mathematical formulas relating to calibrations
• Writes procedures & SOPs for performing calibrations & repairs on measuring equipment in the production & utility areas
• Designs/Redesigns/Evaluates/Optimizes metrology systems & equipment
• Supports and/or executes engineering studies & qualification testing for measuring equipment
• Performs complex calibrations in the areas of temperature, pressure, conductivity, humidity, pH, TOC, flow, mass & frequency
• Maintains critical metrology standards, equipment & tools
• Attains & maintains required site operation & safety certifications. Maintains training qualifications on time

• Planning & Quality Accountabilities

• Supports management & planning department in planning for completion of calibrations
• Reviews & approves calibration documentation for accuracy & completeness
• Identifies & handles deviations & failure investigations per proper procedures. Supports process owners & Metrology Specialist in investigations. Owns investigations & CAPAs as assigned

• Standardization & Continuous Improvement Accountabilities

• Develops work packages & creates plans to support metrology technicians to include required documents, parts & specialized tools or equipment
• Leads calibration activities as scheduled, supported by the Supervisor. Prioritizes & leads unplanned calibration activities based on business need
• Process confirms calibration activities are performed per standards
• Supports Metrology Specialists in developing new or improved calibration methods & procedures
• Ensures team members are trained to the standard.
• Other Accountabilities
• Addresses safety, quality, staffing, or personnel issues & escalates to Supervisor if necessary
• Owns KPI’s or contributes to KPI reporting

• Other accountabilities as assigned

• Addresses safety, quality, staffing, or personnel issues & escalates to Supervisor if necessary
• Owns KPI’s or contributes to KPI reporting
• Other accountabilities as assigned
• Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies

Candidate Qualifications/Experience:

Required Qualifications

• Associates Degree in relevant field or equivalent military or industrial training which includes a thorough understanding of calibration, instrumentation & control systems
• Proficiency in the following areas: Metrology, Calibration, Instrumentation & Controls, Electro-Mechanical systems & Electronics
• Calibration of process & utility instrumentation & calibration field standards
• Experience using electronic calibration management systems such as Calman,SAP, Blue Mountain RAM, ProCal, MAXIMO, etc.
• Able to read & apply schematics, wiring diagrams & other technical documents
• Computer literate with working knowledge of Microsoft Office applications
• Documents problems thoroughly & accurately & brings them rapidly to solution

Desired Qualifications

• 5-10 years relevant metrology/calibration work experience in pharmaceutical or other highly regulated industries
• Demonstrates a high level of organization in task management
• Demonstrates logical planning for task execution & follow-up
• Demonstrates a systematic approach to problem solving & troubleshooting

Physical and Other Requirements:

• Able to move equipment and/or supplies weighing up to 50 pounds within the facility

• Able to routinely operate & inspect manufacturing equipment using hands
• Able to be on feet for up to a 10 hour shift
• Able to transfer materials within manufacturing environment. Frequently moves about the building to access other personnel & operational areas
• Corrected Vision to 20/30 and/or ability to pass vision screening assessment necessary to procure motorized vehicle license
• Able to ascend/descend a ladder to service equipment. Works atop elevated positions at heights
• Able to work around odorous and/or hazardous materials
• Able to work within confined spaces for inspection, repair & maintenance of equipment

• Able to work in loud noise environments with hearing protection

Sagent Pharmaceuticals is an EEO/AA employer and does not discriminate on the basis of race, color, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation.