MDI Manufacturing Operator II - 3rd Shift

CiplaFall River, MA
Onsite

About The Position

The purpose of this role is to assist in manufacturing metered dose inhalation (MDI) products in a pharmaceutical manufacturing company. 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 to include but not limited to Warehouse Operations, Packaging Operations, and Facilities Operations.

Requirements

  • High school diploma or equivalent is required.
  • Minimum 2-3 years of manufacturing experience with MDI or aerosol products required.
  • Proficient in the English language (Speaking/Reading/Writing) to understand work instructions and document results.
  • 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.
  • Ability to wear appropriate PPE is required.
  • Individual 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.

Nice To Haves

  • Accredited college certificate or university degree is preferred.
  • Knowledge of fundamental cGMP and regulatory requirements in a pharmaceutical manufacturing environment highly preferred.
  • Basic understanding of mechanical machinery and the operating principles of control systems.

Responsibilities

  • Dispensing raw material 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 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 co-ordination 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 change over.
  • 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 in a safe and efficient manner.
  • Performing duties through the proper safe use of equipment, according to Health & Safety procedures and Equipment Manuals.
  • Performing other related duties as assigned.
  • 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 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.

Benefits

  • Salary range may vary based on geographic location.
  • In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.
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