Manufacturing Operator

Aurobindo Pharma USA, Inc.•Durham, NC

About The Position

The Manufacturing Operator is responsible for executing all activities related to batch manufacturing and packaging in accordance with established procedures, safety requirements, and quality standards. This includes operating and cleaning equipment, conducting in‑process testing and sampling, performing dispensing activities, supporting calibrations, and troubleshooting machinery as needed. The operator also performs verifications using specialized instruments such as calipers and balances to ensure compliance with product specifications.

Requirements

Ability to follow detailed written procedures and documentation requirements.
Basic understanding of mechanical equipment and troubleshooting.
Strong attention to detail and commitment to quality.
Ability to work independently and within a team environment.
Familiarity with measurement tools (balances, calipers, etc.) preferred.
Be able to effectively communicate with Production team mates, Supervisor and cross functional team including Quality Assurance, Quality Control, Warehouse and Facilities & Engineering.
Ability to stand for extended periods.
Ability to lift, push, or pull up to 50 lbs, as needed.
Ability to work in a manufacturing environment, including exposure to powders, solvents, and machinery.
High school diploma or equivalent / higher required.
Should have wok experience of equipment operation, product changeovers, cleaning and basic operational troubleshooting for at-least 1 – 2 years in Pharmaceutical / Nutraceutical Production (manufacturing and/or packaging).
Familiar with Good documentation and correction practices.
Should have handful experience of GMP document record execution like batch records, logbooks, protocols, etc.
Knowledge of deviations/incidents and CAPA.
A familiarity with cGMPS, CFRs, OSHA and FDA regulations

Nice To Haves

(Experience in Metered dose inhaler (MDIs) production would be preferred).

Responsibilities

Perform batch manufacturing operations according to approved batch records, SOPs, and safety standards.
Execute pharmaceutical processing (filling, coating, cutting, etc) and packaging processes.
Verification of dispensed raw / packaging materials as required.
Conduct in‑process checks and sampling during manufacturing and packaging stages.
Clean and sanitize equipment, tools, and production areas as per Standard Operating Procedures / Protocols.
Assist with basic maintenance, calibration, and verification activities for production equipment.
Troubleshoot equipment issues and escalate when needed to minimize downtime.
Complete all required forms, logs, and documentation accurately and in a timely manner.
Follow all SOPs, GMP guidelines, and safety procedures.
Support departmental requests related to developmental, investigative, or quality‑related activities.
Perform packaging and labeling activities as assigned.
Operate various production equipment safely and efficiently.
Assist in training new operators when required.
Perform other duties as assigned by management.
Make self availability for the cGMP / Hands-On / Classroom trainings and complete all applicable training forms in a timely manner.
Troubleshooting the manufacturing equipment operational issues as needed.