Manufacturing Operator II

Job Title

Manufacturing Operator II

Organization Name

InvaGen Pharmaceuticals, Inc.

Location

Hauppauge, NY 

Employment Type

Full Time 

Salary Range

(Base/salary)

$21.00 - $24.00/hr

Benefits

In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance – medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) – vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid family leave, employee discounts, and other benefits.

Work Hours/ Shift

2nd Shift / 3:00 pm -11:30 pm

Responsibilities/ Accountabilities

• Must be willing to work in a pharmaceutical setting.
• Must be able to know how to operate pharmaceutical production machinery independently and thoroughly complete required documentation (legible writing, accurate reporting, maintain and file, etc.)
• Execute procedures for manufacturing processes in accordance with batch manufacturing record (BMR) and Standard Operating Procedures (SOP) requirements.
• Perform machine changeovers, cleaning and set up as per SOPs. Ensure the proper area & equipment cleanliness and setup in stipulated time.
• Prepare a room and equipment for line clearance, replace room filters, Ensure verification and calibration of balance/scale and check pressure differential for the rooms.
• Ensure line clearance before initiating manufacturing activities in each area.
• Receive/transfer material from/to dispensing/manufacturing storage and check dispensed materials/final mix blend/compressed tablets and labeling as per BMR.
• Wear appropriate personal protective equipment (PPE) as stated in the SOP/BMR before initiating the process.
• Able to operate applicable equipment independently as per area of operation.
• Ensure adherence to quality standards during all stages of the manufacturing process.
• Complete manufacturing documents on time, ensuring accuracy and completeness.
• Responsible for training on all relevant SOPs and always maintain compliance with related SOPs and current Good Manufacturing Practices (cGMP) in the manufacturing process.
• Perform duties through the proper, safe use of equipment, according to Health & Safety procedures and Equipment Manuals.
• Flexible to work extended hours, to achieve manufacturing schedule when needed.
• Maintain discipline and comply with company policies and procedures.
• Perform entire duties as communicated time to time by department management/designee.
• Participate in safety related programs and or safety teams as needed.
• Enforce and follow safety regulations and ensure the working area is clean.
• Adhere to CIPLA’s Safety, Health, and Environmental policies.
• Must be able to work under general supervision and able to work independently and in a team environment.
• Must be able to exercise appropriate professional judgment on matters of significance.
• Other duties assigned by Manufacturing Management.

Education Qualifications/Experience

• High School Diploma (or educational equivalent (i.e. GED)
• Minimum three years of direct work experience in pharmaceutical manufacturing. 
• Preference will be given to candidates with experience in generic pharmaceutical manufacturing.

Skills/ Competencies

• Must have legible handwriting, and the ability to perform accurate documentation.
• Understanding of granulation, compression, coating, and encapsulation machines.
• Capable of conducting troubleshooting, investigations and root cause identification and analysis. 
• Able to prioritize, plan and work under tight schedules and deadlines.
• Technical writing skills and application of relevant scientific principles and practices (preferred).
• Must communicate clearly and concisely, both orally and in written.
• English proficiency required.

Physical Requirements

• Should not have any restriction to work with powder containing active pharmaceutical ingredients.
• This position requires the ability to do heavy lifting / bending frequently.
• Long periods of standing up/walking during the working hours; ability to ascend/descend ladders; and able to lift to 35 pounds.
• Must be able to move pallets/equipment weighing about 200 – 300 kgs using suitable moving equipment like pallet jacks.