Manufacturing Operator I - 2nd Shift

Cipla; 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 team in Fall River. In this role, you will be at the forefront of producing high-quality Metered Dose Inhaler products, ensuring compliance with industry standards and safety regulations. You'll be responsible for various tasks, including dispensing materials, operating machinery, and maintaining production efficiency. This position offers the chance to work in a collaborative environment where your contributions directly impact the quality of life for patients worldwide. If you're passionate about manufacturing and eager to grow in a dynamic pharmaceutical setting, this opportunity is perfect for you.

Qualifications

• Minimum one year of manufacturing experience in the pharmaceutical industry.
• Knowledge of cGMP and regulatory requirements is highly preferred.

Responsibilities

• Dispensing raw materials and planning manufacturing batches effectively.
• Monitoring daily production performance and documenting activities.
• Collaborating with packaging, maintenance, and quality teams.

Skills

Manufacturing Experience

cGMP Knowledge

Basic Mechanical Skills

Mathematical Skills

Organizational Skills

English Proficiency

Education

High School Diploma

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

Reports To: Manufacturing Supervisor

Job Summary

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

Essential Duties and Responsibilities

1. Dispensing raw materials and primary packing materials according to work orders and verifying their accuracy.
2. Planning and executing manufacturing batches effectively.
3. Cleaning and sanitizing production areas and machinery per procedures.
4. Monitoring daily production performance.
5. Documenting manufacturing activities in batch records and logbooks.
6. Operating machinery with minimal rejections and maintaining quality standards.
7. Performing equipment operation and maintenance.
8. Coordinating with engineering for preventive maintenance and calibration.
9. Maintaining inventory of machine parts, tools, and accessories.
10. Working independently and collaboratively within a team.
11. Collaborating with packaging, maintenance, and quality teams.
12. Ensuring proper labeling at all manufacturing stages.
13. Identifying and assisting with corrective actions.
14. Calibrating and verifying instruments and equipment as scheduled.
15. Performing line clearance checks.
16. Wearing appropriate PPE as per SOP before entering processing areas.
17. Following safety and operational procedures.
18. Utilizing equipment safely and according to health & safety guidelines.
19. Performing other related duties as assigned.
20. Operating computer systems effectively.
21. Understanding pharmaceutical manufacturing documents and processes.
22. Basic knowledge of deviation, CAPA, change control, FMECA, OOS, OOT, and OOAC processes.

Other Responsibilities

1. Maintaining 100% compliance with cGMP, GDP, and SOPs during all operations.
2. Adhering to company policies and procedures.
3. Reporting issues promptly to supervisors.
4. Performing daily equipment maintenance.
5. Completing documentation accurately and timely.
6. Maintaining discipline within the department.
7. Assisting in training new employees as needed.
8. Willingness to work extended hours to meet manufacturing schedules.

Training and Safety

All employees must undergo 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 machinery and PPE use.

Qualifications

• High school diploma or equivalent required; college degree preferred.
• Minimum one year of manufacturing experience in the pharmaceutical industry; MDI experience highly preferred.
• Proficiency in English (speaking, reading, writing).
• Knowledge of cGMP and regulatory requirements is highly preferred.
• Basic mechanical skills and understanding of control systems.
• Ability to follow instructions and work independently or in teams.
• Knowledge of OSHA and safety procedures.
• Strong mathematical and organizational skills.

Physical Requirements

• Ability to perform heavy lifting, bending, and manual tasks frequently.
• Force exertion up to 50 pounds with equipment assistance.
• Wearing PPE and respiratory devices as required.

About the Company

Cipla is a leading global pharmaceutical company committed to high-quality medicines. We value our employees as our greatest assets and focus on making affordable, world-class medicines with uncompromising quality standards. InvaGen Pharmaceuticals, a Cipla subsidiary, specializes in developing and manufacturing generic prescription medicines across various therapeutic areas.