Manufacturing Operator - Pharmaceuticals

Umanist; Fall River (MA); On-site; USD 30,000 - 50,000; Full time

Job summary

An established industry player is seeking a Manufacturing Operator I to join their dynamic team in Fall River. This role involves ensuring compliance with cGMP standards while producing high-quality Metered Dose Inhaler products. The successful candidate will work collaboratively across teams, operate machinery efficiently, and maintain safety protocols. With a focus on precision and quality, this position offers an exciting opportunity to contribute to the pharmaceutical manufacturing process. If you have a passion for production and a commitment to excellence, this is the perfect role for you!

Qualifications

• 1+ years of manufacturing experience in the pharmaceutical industry.
• Strong knowledge of cGMP and regulatory requirements.

Responsibilities

• Dispense raw materials and ensure accurate planning of batches.
• Monitor production performance and document activities.
• Perform cleaning and sanitation of production areas.

Skills

cGMP knowledge

documentation and record-keeping

organizational skills

health & safety procedures

mechanical machinery understanding

mathematical skills

English proficiency

calibration

Education

High school diploma or equivalent

Accredited college certificate or university degree

Job description

Job Title: Manufacturing Operator I

Location: Fall River, MA

Work Hours

• 1st Shift: 07:00 AM – 03:30 PM
• 2nd Shift: 03:00 PM – 11:30 PM
• 3rd Shift: 11:00 PM – 07:30 AM (Flexibility is requested based on business needs)
  
  

Position Overview

The Manufacturing Operator I will perform all functions related to the production of MDI (Metered Dose Inhaler) products, in accordance with Current Good Manufacturing Practices (cGMP), customer requirements, and all Standard Operating Procedures (SOPs). The role involves ensuring the safe, efficient, and compliant execution of manufacturing tasks while maintaining high-quality standards throughout the production process.

Key Responsibilities

• Dispense raw materials and primary packaging materials as per work order and check materials for accuracy.
• Ensure proper planning and execution of batches.
• Perform cleaning and sanitation of production areas and machinery as per respective procedures.
• Monitor daily production performance and document activities in batch records and logbooks.
• Operate machinery with minimum rejections and maximum output while maintaining quality standards.
• Perform necessary maintenance on machinery and coordinate with engineering for preventive maintenance and calibration.
• Maintain inventory of machine parts, tools, and accessories.
• Collaborate with packaging, maintenance, and quality teams for cross-functional activities.
• Perform line clearance checks and ensure status labeling during manufacturing, filling, and cleaning.
• Assist in corrective actions when required and perform calibration/verification of instruments as scheduled.
• Wear appropriate PPE as specified in the SOP and follow all safety procedures.
• Complete documentation in a timely manner, ensuring integrity, accuracy, and completeness.
• Participate in training and maintain compliance with all safety, health, and environmental guidelines.
  
  

Other Responsibilities

• Maintain 100% cGMP, GDP, and SOP compliance throughout operational hours.
• Report all issues or concerns to the department head or reporting manager.
• Assist in training other employees in the department.
• Be flexible to work extended hours to meet production goals.
• Cross-train in different areas of manufacturing operations as needed.
  
  

Qualifications

• Education: High school diploma or equivalent required; accredited college certificate or university degree preferred.
• Experience: Minimum of 1 year of manufacturing experience in the pharmaceutical industry, MDI experience highly preferred.
• Skills:
• Strong knowledge of cGMP and regulatory requirements in pharmaceutical manufacturing.
• Experience in documentation and record-keeping according to industry and FDA standards.
• Good understanding of Health & Safety procedures, including OSHA.
• Proficient in the English language (speaking/reading/writing) to understand work instructions and document results.
• Basic understanding of mechanical machinery and operating principles.
• Ability to follow both verbal and written instructions and work independently and in a team environment.
• Strong organizational and mathematical skills.
  

Physical Requirements

• Ability to perform heavy lifting, bending, and exert force using equipment (e.g., hand truck).
• Ability to wear appropriate PPE, including respiratory devices when required.
  
  

Work Authorization

• U.S. Citizen or Green Card Holder required.
  
  

Shift Details

• 1st Shift: 07:00 AM – 03:30 PM (1 Position)
• 2nd Shift: 03:00 PM – 11:30 PM (12 Positions)
• 3rd Shift: 11:00 PM – 07:30 AM (12 Positions)
  
  

Skills: instructions,machinery,cgmp knowledge,documentation and record-keeping,calibration,documentation,manufacturing,organizational skills,regulatory compliance,materials,mathematical skills,health & safety procedures,english proficiency,mechanical machinery understanding,health,mdi,maintenance