Metrologist I

Job Summary

Sun Pharma is seeking a skilled Metrologist I to join our team in the laboratory. As a Metrologist I, you will be responsible for performing and assisting with all essential tasks related to the calibration and qualification of laboratory instruments. This includes preventative maintenance, calibration, and qualification of laboratory instruments in accordance with all applicable SOPs to ensure adherence to cGMP in support of the laboratory operation.

Key Responsibilities

• Develop and implement a master Preventive Maintenance/Calibration schedule.
• Plan, execute, and review instrument calibration/qualification related activities as per the calibration master plan.
• Draft and review instrument operation, maintenance, and calibration procedures.
• Initiate change controls for new and existing instruments and their procedures.
• Concurrently document all raw data, observations in notebooks or applicable documents.
• Notify supervisors of anomalous or out-of-control results. Notify management of any observations or deviations.
• Adhere to cGMP and safety procedures.
• Review and report applicable calibration/qualification documents.
• Log and attend instrument repair requests.
• Schedule visits for outside contractors for preventive maintenance or repair.
• Place "out of service" tags on instruments due for calibration, instruments requiring repair, or new instruments.
• Open investigations and conduct primary investigations under direct guidance from management.
• Ensure adequate labeling of all instruments and ensure instrument calibration status.
• Order and maintain spare parts for major instruments to ensure continuous support of analysis.
• Verify the expiry date of chemicals, reagents, primary calibrators prior to use.

Work Environment

The Metrologist I will work in a manufacturing/production/laboratory environment. The work environment may include:

• Noise: Sufficient noise to cause distraction or possible injury to hearing.
• Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
• Odors: Unpleasant smells.
• Gases: Examples include carbon monoxide and helium.
• Dust: Airborne particles of any kind, such as textile dust, wood, and silica.
• Hazards: Conditions where there is danger to life, health, or bodily injury, such as closeness to moving mechanical parts; working on scaffolding and high places; exposure to burns, radiant energy, explosives, toxic chemicals, and electric shock.

Physical Requirements

• Able to lift and carry up to 50 lbs.
• Frequently required to sit; use hands to finger, handle objects, or feel objects, tools, or controls; and reach with hands and arms.
• Occasionally required to stand, stoop, kneel, and crouch.
• Specific vision abilities required include close vision, distance vision, color vision, and the ability to adjust focus.

Travel Estimate

Up to 5%

Education and Job Qualifications

• Minimum BS or equivalent degree in Chemistry or related discipline.
• In-depth knowledge of analytical instrumentation such as HPLC, GC, FTIR, UV, and practice.
• Practical problem-solving skills for instrumentation troubleshooting.
• Knowledge of ICH and FDA regulatory guidance.
• Familiarity with cGMP/GLP practices for analytical laboratories and EHS/OSHA safety regulations.
• Excellent written and verbal communication skills and working knowledge of Microsoft Office Applications.
• A self-starter with a hands-on approach and a can-do attitude.
• Intermediate-B1+ (comparable to Global CEFR Independent B1) level English language proficiency.

Experience

• Minimum of two years of Pharmaceutical Industry Laboratory experience.