Manufacturing Operator

The Manufacturing Operator position at our Fall River, MA project site is of great importance to our metered dose inhalation (MDI) products. This role entails not only supervising manufacturing operations for MDI products, but also ensuring strict adherence to Current Good Manufacturing Practices (cGMP), customer specifications, and Standard Operating Procedures (SOP). Apart from these responsibilities, the Manufacturing Operator also plays a versatile role by providing support to various operational functions such as Warehouse Operations, Packaging Operations, and Facilities Operations whenever the need arises.

Responsibilities:

• Dispensing raw materials and primary packing materials in accordance with work orders.
• Efficiently planning and executing batches.
• Monitoring and maintaining cleanliness and sanitation of the production area and machinery during batch-to-batch and product-to-product changeovers.
• Recording production materials and lines on a daily basis.
• Performing in-process checks and accurately recording data in batch manufacturing records.
• Controlling machine operations to minimize rejections and maximize outputs while maintaining quality standards.
• Operating equipment, conducting maintenance, and coordinating with engineering for preventive maintenance and calibration.
• Filling products in accordance with Batch Manufacturing Records and SOP.
• Managing inventory of machine parts, tools, and accessories.
• Collaborating with other departments for planning and execution.
• Sampling and coordinating with QA and QC teams.
• Ensuring calibration/verification of instruments, equipment, and weighing balances.
• Conducting line clearance during changeovers.
• Accurately and timely documenting manufacturing and filling operations and activities.
• Adhering to safety protocols and wearing appropriate personal protective equipment (PPE).
• Executing tasks in a safe and efficient manner in accordance with Health & Safety procedures.
• Completing assigned duties and other responsibilities.

Other Responsibilities:

• Ensuring strict adherence to cGMP and SOP guidelines.
• Promptly reporting any issues to department heads or reporting managers.
• Performing routine equipment maintenance on a daily basis.
• Accurately and punctually completing all required documentation.
• Maintaining a disciplined and professional environment within the department.
• Providing assistance in training and development of fellow employees.
• Demonstrating flexibility by being available for extended working hours as necessary to meet manufacturing schedules.

Requirements

• High school diploma or equivalent; advanced vocational training or education preferred.
• Minimum one (1) year of manufacturing experience with MDI or aerosol products.
• Proficiency in English (Speaking/Reading/Writing) to understand work instructions and document results.
• Basic understanding of cGMP and regulatory requirements in pharmaceutical manufacturing.
• Familiarity with mechanical machinery and control systems.
• Ability to follow verbal and written instructions.
• Demonstrated ability to work independently and in team environments.
• Knowledge of Health & Safety procedures, including OSHA.
• Strong mathematical and organizational skills.

Physical Requirements:

This role requires frequent heavy lifting and bending, as well as the consistent use of appropriate Personal Protective Equipment (PPE). The individual may also be occasionally required to wear respiratory devices as deemed necessary.

Training and Safety:

All employees will participate in a range of training activities, and Operators may be requested to undergo cross-training in all aspects of manufacturing operations. It is essential to strictly adhere to safety, health, and environmental guidelines while handling equipment.

Benefits

• Two weeks of vacation time
• Sick time
• Medical Insurance
• Dental Insurance
• Vision Insurance
• 401k