Manufacturing Operator

Job Description

Job Title: Manufacturing Operator - 2nd Shift

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

Work Location: Hauppauge, NY

Work Hours: Second Shift: 3:00 PM – 11:30 PM (May vary based on business needs)

Reports To: Facilities Operations Manager

Purpose

The purpose of this role is to assist in oral solid dosage products in a pharmaceutical manufacturing company.

Scope

The scope (content and statements) of this job description is designed to describe the general nature and level of work as well as provide a basic understanding of the role, responsibilities, and expectations of the person assigned to perform the job. This job description is not designed to provide an exact or exhaustive list of all job duties, tasks, skills, and qualifications. The intent is to give a general scope of the knowledge, skills, and abilities needed to satisfactorily perform the essential functions of the position and provide basic performance expectations. The scope of the job may be modified with respect to the department, group, and on an individual assigned basis to a sometimes-specific testing group. Consideration of education, relevant training, and experience or a combination of all three may also result in further modification of the role.

Multifunctional Role

This job is a multifunctional role. The primary nature of this job is to serve as a Manufacturing Operator. As a secondary requirement, this position will be expected to provide support to other operational functions including but not limited to Warehouse Operations, Packaging Operations, and Facilities Operations.

Job Description

The Manufacturing Operator performs all functions relating to the production of oral solid dosage products; consistent with established Current Good Manufacturing Practices (cGMP), customer requirements, and in conjunction with all Standard Operating Procedures (SOP). Incumbents in this position are responsible for the safe and efficient execution of their job duties while ensuring product compliance to established standards.

Essential Duties And Responsibilities

• Dispensing raw materials and primary packing materials as per work order.
• Ensure the proper planning and execution of batches.
• Monitoring cleaning and sanitation of production area and machinery as per respective SOP during batch-to-batch and product-to-product changeover.
• Daily monitoring and recording of production materials and production lines.
• Conducting in-process checks and recording in batch manufacturing record.
• Controlling machine operations with minimum rejections and maximum outputs while maintaining quality standards within the standard norms.
• Operating equipment and performing necessary maintenance on machinery.
• Safeguard equipment for smooth functioning with coordination of engineering for preventive maintenance and calibration.
• Manufacturing and filling of products as per Batch Manufacturing Records and SOP.
• Maintaining inventory of machine parts, tools, and accessories.
• Working individually and in collaboration with others as part of a team.
• Coordinating with other departments like packaging, engineering, QA, and QC for better planning and execution.
• Sampling as per schedule and in coordination with QA and QC.
• Check and ensure status labels at all stages of manufacturing and filling.
• Identifying and assisting in any corrective actions.
• Perform, check, and ensure calibration/verification of instruments, equipment, and weighing balances as per schedule.
• Ensuring line clearance during batch-to-batch and product-to-product changeover.
• Online documentation and timely entries related to manufacturing and filling operations and activities.
• Wearing appropriate PPE as stated in the SOP before entering any processing areas.
• Executing procedures to complete tasks safely and efficiently.
• Performing duties through the proper safe use of equipment, according to Health & Safety procedures and Equipment Manuals.
• Performing other related duties as assigned.

• Other Responsibilities

  
  

  • Maintaining 100% cGMP and SOP Compliance during complete operation hours.
  • Complying with all company policies and procedures.
  • Reporting all issues that arise to the department head or reporting manager.
  • Performing daily maintenance on equipment and machinery.
  • Completing all documentation in a timely manner, ensuring their integrity, accuracy, and completeness.
  • Maintaining discipline in the department.
  • May be required to assist in the training of other employees in the department.
  • Flexible to work extended hours, to achieve manufacturing schedule when needed.

• Training And Safety

  
  

  All employees must undergo various training activities at the start of their employment. New training and re-training will occur periodically. Operators may be required to cross-train in all areas of the manufacturing operations. Employees must strictly adhere to all safety, health, and environmental guidelines at all times and ensure that all safety precautions are being taken during the handling of machines.

  
  

  Qualification

  
  

  • A high school diploma or equivalent is required.
  • An accredited college certificate or university degree is preferred.
  • A minimum one (1) year of manufacturing experience with Oral Solid Dosage is required.
  • Proficient in the English language (Speaking/Reading/Writing) to understand work instructions and document results.
  • Knowledge of fundamental cGMP and regulatory requirements in a pharmaceutical manufacturing environment is highly preferred.
  • Basic understanding of mechanical machinery and the operating principles of control systems.
  • Ability to follow both verbal and written instructions.
  • Demonstrated ability to work in both independent and team environments.
  • Good knowledge of Health & Safety procedures, including, OSHA.
  • Strong mathematical and organizational skills.

• Physical Requirements

  
  

  • This position requires the ability to do heavy lifting/bending frequently.
  • Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.
  • The ability to wear appropriate PPE is required.
  • Individuals may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air-purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.