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Metrology Specialist Iii

6+ years
$80,000 to $94,000
10 Nov. 28, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Calibration Technician (Metrology Support)
Company: Sun Pharmaceuticals
Location: Not specified (assumed to be at a manufacturing or production facility)


Job Summary

The Calibration Technician will be responsible for providing metrology support to ensure that manufacturing and quality control instruments function properly within a laboratory or production environment. This includes performing installation, calibration, maintenance, troubleshooting, and repair duties on various critical laboratory, process, and utility instruments. The technician will work closely with maintenance, operations, and automation teams while adhering to Standard Operating Procedures (SOPs) in a cGMP facility. The role requires documentation of calibration activities and root cause analysis for deviations using a Quality Management System (QMS).


Key Responsibilities

  • Calibration Support: Calibrate and maintain equipment such as lyophilizers, fillers, RO systems, WFI stills, clean steam generators, autoclaves, CIP systems, and lab instrumentation.

  • Process and Instrumentation Improvements: Review and implement process improvements related to calibration testing methods, ensuring the highest quality standards are met.

  • Vendor Coordination: Schedule, perform, and coordinate calibration activities with external vendors, addressing both scheduled and emergency calibration needs.

  • Documentation and Compliance: Maintain calibration records, tag instruments, and write SOPs for calibration and maintenance processes.

  • Deviation Management: Lead technical writing for deviations, CAPA (Corrective and Preventive Actions), and change control records.

  • Project and Audit Support: Serve as the calibration technical lead for projects and audits. Assist in troubleshooting issues with instrumentation and support the maintenance of lab equipment.

  • Inventory and Spare Parts Management: Manage spare parts inventory for critical instruments to ensure readiness and minimal downtime.

  • Other Duties: Assist with troubleshooting, preventive maintenance, and other activities as required.


Work Environment and Conditions

  • Work Locations:

    • Office

    • Lab

    • Manufacturing/cleanroom area

    • Maintenance shop

  • Environmental Exposure: Noise, hot/cold temperatures, radiation exposure, and use of autoclaves.

  • Physical Requirements:

    • Ability to stand, sit, walk, bend, and lift up to 25 lbs.

    • Use of hands and fingers for equipment handling, and close and distance vision.

    • Requires wearing personal protective equipment such as safety glasses, gloves, and gowning.

    • Occasional work with autoclaves and office/maintenance machines.


Education and Job Qualifications

  • Education:

    • High school diploma or equivalent required.

    • Knowledge of metrology principles as defined by ANSI/NCSL is essential.

  • Experience:

    • 6+ years of related experience preferred.

    • Experience calibrating critical instrumentation in a pharmaceutical or laboratory environment, such as temperature, pressure, flow, pH, conductivity, humidity, etc.

    • Proficiency with Blue Mountain calibration software.

  • Skills and Competencies:

    • Strong organizational, communication, and interpersonal skills.

    • Ability to work independently and meet deadlines with minimal supervision.

    • Familiarity with FDA, cGMP, ISO, and SOPs.


Compensation and Benefits

  • Base Salary: $80,000 to $94,000 (based on geographical location and experience).

  • Performance Bonus: Eligible for the Annual Performance Bonus Plan.

  • Benefits:

    • Comprehensive medical, dental, and vision coverage.

    • Life insurance, disability insurance, 401(k) savings plan.

    • Flexible spending accounts, employee assistance programs.

    • Paid time off, including vacation and sick days.


Equal Employment Opportunity

Sun Pharmaceuticals is committed to equal employment opportunities and does not discriminate against any applicant based on race, religion, sex, disability, or other protected characteristics.


Notice to Agencies

Sun Pharmaceuticals does not accept unsolicited resumes from agencies or search firms. Resumes submitted without a valid search agreement will become the sole property of Sun Pharmaceuticals, and no fee will be paid.


How to Apply

Interested candidates should apply directly through Sun Pharmaceuticals' career portal or the relevant channels.