Manufacturing Operator II

Job Title:

Manufacturing Operator II

Location:

Hauppauge, NY

Employment Type:

Full time / Hourly

Salary Range: $22.00 - $29.00/hr

Work Hours:

2 nd shift 3:00 PM –11:30 PM

The Manufacturing Operator is responsible for executing pharmaceutical production processes in compliance with Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMR), and current Good Manufacturing Practices (cGMP). This role involves operating and maintaining production machinery, performing equipment changeovers, cleaning, and ensuring proper line clearance. The operator will handle material transfers, verify equipment calibration, and maintain strict adherence to quality, safety, and environmental standards.

The position requires accurate documentation and the ability to work independently or as part of a team under general supervision. Additional responsibilities include participating in safety programs, enforcing compliance with company policies, and supporting continuous improvement initiatives.

• Operate pharmaceutical production machinery independently.
• Execute manufacturing processes in accordance with Batch Manufacturing Records (BMR) and Standard Operating Procedures (SOPs).
• Perform machine changeovers, cleaning, and setup as per SOPs; ensure proper area and equipment cleanliness within stipulated time.
• Prepare rooms and equipment for line clearance, replace room filters, verify and calibrate balances/scales, and check pressure differentials.
• Ensure line clearance before initiating manufacturing activities in each area.
• Receive and transfer materials between dispensing and manufacturing storage; check dispensed materials, final mix blend, compressed tablets, and labeling as per BMR.
• Wear appropriate personal protective equipment (PPE) as stated in SOP/BMR before initiating processes.
• Ensure adherence to quality standards during all stages of the manufacturing process.
• Complete manufacturing documentation accurately and on time.
• Maintain compliance with SOPs and current Good Manufacturing Practices (cGMP) throughout the manufacturing process.
• Operate equipment safely according to Health & Safety procedures and equipment manuals.
• Participate in safety-related programs and/or safety teams as needed.
• Enforce and follow safety regulations and maintain a clean working area.
• Adhere to Safety, Health, and Environmental policies.
• Perform other duties as assigned by Manufacturing Management.

• High School Diploma (or equivalent).
• Minimum three (3) years of direct work experience in pharmaceutical manufacturing.
• Experience in generic pharmaceutical manufacturing preferred.

• Understanding 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.
• Must possess strong documentation and technical writing skills.
• Must be able to clearly communicate in English (verbal and written).

• Frequently lift, bend, and carry up to 35 lbs. throughout the shift.
• Stand or walk for extended periods; climb ladders as needed.
• Use pallet jacks to move up to 200–300kg of equipment and materials.
• No restrictions on working with powder containing active pharmaceutical ingredients.

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 and…