Manufacturing Operator I - 1st Shift

Cipla USA; Fall River (MA); On-site; USD 35,000 - 55,000; Full time

Job summary

An established industry player seeks a dedicated Manufacturing Operator to join their dynamic team in Fall River. This role involves ensuring compliance with cGMP standards while executing production tasks efficiently. You will dispense materials, monitor production performance, and maintain high-quality standards in a collaborative environment. If you have a passion for pharmaceutical manufacturing and a commitment to excellence, this opportunity offers a chance to contribute to impactful projects in a supportive workplace that values its employees as its greatest asset.

Qualifications

• High school diploma required, college degree preferred.
• 1+ years of manufacturing experience in pharmaceuticals.

Responsibilities

• Dispense raw materials and monitor production performance.
• Document manufacturing activities accurately in batch records.
• Operate machinery and perform routine maintenance.

Skills

Manufacturing Experience

cGMP Knowledge

Basic Mechanical Understanding

Mathematical Skills

Organizational Skills

English Proficiency

Education

High School Diploma

College Certificate or Degree

Tools

Computer Systems

Job description

Job Title: Manufacturing Operator 1

FLSA Classification: Full-Time, Non-Exempt/Hourly Professional

Work Location: Fall River, MA

Work Hours: First Shift: 7:00 AM - 3:30 PM (Flexibility is requested based on business needs)

Reports To: Manufacturing Supervisor

The Manufacturing Operator performs all functions related to the production of MDI (Metered Dose Inhaler) products, ensuring compliance with established cGMP, customer requirements, and SOPs. Responsibilities include the safe and efficient execution of job duties and maintaining product quality standards.

Essential Duties and Responsibilities

1. Dispense raw materials and primary packing materials as per work order, checking their quality.
2. Plan and execute manufacturing batches effectively.
3. Perform cleaning and sanitation of production areas and machinery following procedures.
4. Monitor daily production performance.
5. Document manufacturing activities accurately in batch records and logbooks.
6. Operate machinery with minimal rejections, maximizing output while maintaining quality.
7. Perform routine maintenance and calibration of equipment.
8. Coordinate with engineering for preventive maintenance and calibration schedules.
9. Maintain inventory of machine parts, tools, and accessories.
10. Work independently and collaboratively within a team environment.
11. Collaborate with packaging, maintenance, and quality teams for cross-functional activities.
12. Ensure proper labeling at all manufacturing stages.
13. Identify and assist in corrective actions as needed.
14. Verify calibration and verification of instruments and equipment.
15. Perform line clearance checks.
16. Wear appropriate PPE as per SOP before entering processing areas.
17. Follow safety procedures to complete tasks safely and efficiently.
18. Operate equipment safely according to health and safety guidelines.
19. Perform additional duties as assigned.
20. Operate computer systems proficiently.
21. Understand pharmaceutical manufacturing documentation.
22. Basic knowledge of deviation, CAPA, change control, FMECA, OOS, OOT, and OOAC processes.

Other Responsibilities

1. Maintain 100% compliance with cGMP, GDP, and SOP during operations.
2. Follow all company policies and procedures.
3. Report issues promptly to the department head or manager.
4. Perform daily maintenance on equipment.
5. Complete documentation accurately and timely.
6. Maintain discipline within the department.
7. Assist in training new employees as required.
8. Work extended hours as needed to meet manufacturing schedules.

Training and Safety

All employees must complete initial and periodic training. Cross-training across manufacturing areas may be required. Strict adherence to safety, health, and environmental guidelines is mandatory, including proper handling of machines and PPE usage.

Qualifications

• High school diploma or equivalent required.
• College certificate or degree preferred.
• Minimum one year of manufacturing experience in the pharmaceutical industry; MDI experience highly preferred.
• Proficient in English (spoken, reading, writing).
• Knowledge of cGMP and regulatory standards preferred.
• Basic mechanical and control system understanding.
• Ability to follow instructions and work independently or in a team.
• Knowledge of OSHA and health & safety procedures.
• Strong mathematical and organizational skills.

Physical Requirements

• Ability to perform heavy lifting, bending, and physical exertion.
• Ability to wear PPE and respiratory devices as required.

About Cipla

Cipla is a leading global pharmaceutical company committed to high-quality, affordable medicines, with a presence in India, South Africa, the U.S., and other emerging markets. We value our employees as our greatest assets, driven by our vision that 'none shall be denied.'

InvaGen Pharmaceuticals, Inc.

As a Cipla subsidiary, InvaGen develops, manufactures, and markets generic medicines across various therapeutic areas, based in New York, and operating as part of Cipla since 2016.