Manufacturing Operator I - 2nd Shift

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

Job summary

An established industry player is seeking a Manufacturing Operator to join their team in Fall River. This role is essential for the production of Metered Dose Inhaler products, ensuring compliance with safety and quality standards. The ideal candidate will have a strong background in pharmaceutical manufacturing, with a focus on cGMP practices. You will work collaboratively with various teams while also being able to operate independently. This position offers a unique opportunity to contribute to high-quality healthcare solutions, making a difference in patients' lives. If you are passionate about the pharmaceutical industry and eager to grow, this role is perfect for you.

Qualifications

• Minimum one year of pharmaceutical manufacturing experience.
• Knowledge of cGMP and regulatory standards preferred.

Responsibilities

• Dispense raw materials and verify for production.
• Monitor daily production performance and maintain compliance.

Skills

Pharmaceutical Manufacturing

cGMP Knowledge

Mechanical Understanding

Organizational Skills

Mathematical Skills

Safety Procedures

Team Collaboration

Independent Work

Education

High School Diploma

Higher Education (Preferred)

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: Second Shift: 3:00 PM to 11:30 PM (Flexibility is requested based on business needs)

Reports To: Manufacturing Supervisor

Job Overview

The Manufacturing Operator performs functions related to the production of MDI (Metered Dose Inhaler) products, adhering to established cGMP, customer requirements, and SOPs. Responsibilities include ensuring safety, efficiency, and product compliance with quality standards.

Essential Duties and Responsibilities

1. Dispense raw and primary packing materials per work orders and verify materials.
2. Plan and execute manufacturing batches properly.
3. Clean and sanitize production areas and machinery according to procedures.
4. Monitor daily production performance.
5. Record manufacturing activities in batch records and logbooks.
6. Operate machinery with minimal rejects and maximum quality.
7. Perform equipment operation and maintenance.
8. Coordinate with engineering for preventive maintenance and calibration.
9. Maintain inventory of machine parts, tools, and accessories.
10. Work independently and collaboratively within a team.
11. Coordinate with packaging, maintenance, and quality teams.
12. Label products at all manufacturing stages.
13. Identify and assist in corrective actions.
14. Calibrate and verify instruments and equipment as scheduled.
15. Conduct line clearance checks.
16. Wear PPE as per SOP before entering processing areas.
17. Follow safety procedures for task completion.
18. Operate equipment safely according to health and safety guidelines.
19. Perform other assigned duties.
20. Operate computer systems proficiently.
21. Understand pharmaceutical manufacturing documentation.
22. Basic knowledge of deviation, CAPA, change control, and related processes.

Other Responsibilities

1. Maintain 100% cGMP, GDP, and SOP compliance.
2. Follow company policies and report issues.
3. Perform routine maintenance on equipment.
4. Complete documentation accurately and timely.
5. Maintain discipline within the department.
6. Assist in training employees if required.
7. Work extended hours if needed to meet schedules.

Training and Safety

All employees must undergo initial and periodic training, including cross-training. Strict adherence to safety, health, and environmental guidelines is mandatory, including proper handling of machinery and PPE usage.

Qualifications

1. High school diploma or equivalent required; higher education preferred.
2. Minimum one year of pharmaceutical manufacturing experience; MDI experience preferred.
3. Proficient in English (speaking, reading, writing).
4. Knowledge of cGMP and regulatory standards preferred.
5. Basic mechanical and control system understanding.
6. Ability to follow instructions and work independently or in teams.
7. Knowledge of OSHA safety procedures.
8. Strong organizational and mathematical skills.

Physical Requirements

1. Ability to lift heavy objects frequently.
2. Ability to wear PPE and respiratory devices as required.
3. Capability to perform physical tasks like bending and lifting.

About Cipla

Cipla is a leading global pharmaceutical company dedicated to high-quality medicines. We value our employees as our greatest assets and are committed to making healthcare affordable and accessible worldwide.

InvaGen Pharmaceuticals, Inc.

InvaGen, a Cipla subsidiary, develops and manufactures generic medicines with a focus on various therapeutic areas. Founded in 2003, based in New York, and part of Cipla since 2016.