Pilot Plant Manufacturing Operator

Job Title: Pilot Plant Machine Operator

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

Work Location: Fall River, MA

Work Hours: General Shift: 8:30AM a" 5:00PM (May vary based on business needs)

Reports To: R&D Supervisor

Pay Range: $20 - 25

Purpose:

The purpose of this role is to assist in manufacturing and packaging metered dose inhalation (MDI) products in a pharmaceutical manufacturing company.

Scope:

The scope 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. 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 Machine Operator. As a secondary requirement, this position will be expected to provide support to other operational functions including but not limited to Warehouse Operations and Facilities Operations.

Job Description:

The Machine Operator performs all functions relating to the production of MDI 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 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, filling and packing of products as per Batch Manufacturing and Packing 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.

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 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. Machine Operators are required to be cross-trained 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 handling of machines.

Qualifications:

• High school diploma or equivalent is required.
• Accredited college certificate or university degree is preferred.
• Minimum one (1) year of manufacturing and packing experience with MDI or aerosol products 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 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.
• 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. (Fit Testing may be required as part of employee onboarding).

GLOBAL COMPANY

Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in Indiaas pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.

Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees, who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Ciplaas focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)

About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.