Transdermal Operator III -Day Shift

Amneal Pharmaceuticals; Piscataway Township (NJ); On-site; USD 77,366,000 - 100,289,000; Full time

Job summary

Amneal Pharmaceuticals seeks a Transdermal Operator III to lead batch production, run equipment, and support qualification activities in a GMP environment. You will mentor other operators, manage set-up, IQ/OQ/PQ, and ensure documentation accuracy.

The role requires 5+ years in manufacturing or GMP, strong math and mechanical skills, fluent English, and willingness to extend hours. Shift: Day 12-hour shifts on a rotating schedule; weekend requirements apply.

Qualifications

• High School diploma or GED is required.
• 5+ years of related manufacturing or GMP experience.
• Must be able to understand and communicate in English.
• Strong math and mechanical skills; data entry ability.
• Willingness to work extended hours when required.

Responsibilities

• Lead other operators during batch execution and qualifications.
• Execute production schedule with equipment/material readiness.
• Assist Supervisor to resolve issues; determine root causes.
• Monitor GMP, SOP compliance; document logs accurately.
• Perform IQ/OQ/PQ and equipment setup for batches.
• Train new personnel on SOPs and equipment.

Skills

English communication

Math skills

Mechanical skills

Flexibility

Education

High School diploma or GED

Job description

JOB DESCRIPTION

The Transdermal Operator III responsibilities includes equipment start-up, participation in ANDA batch production and commercial batch manufacturing. Primary responsibilities includes training, transdermal mixing, coating, converting, packaging, and cartoning. The Transdermal Operator III is an expert in converting, (die cutting) and will provide support with troubleshooting.

JOB SUMMARY

The Transdermal Operator III responsibilities includes equipment start-up, participation in ANDA batch production and commercial batch manufacturing. Primary responsibilities includes training, transdermal mixing, coating, converting, packaging, and cartoning. The Transdermal Operator III is an expert in converting, (die cutting) and will provide support with troubleshooting.

Day Shift – 12-hour per day, rotating schedule (6:00am-6:30pm) 3 days week 1 and 4 days week 2 of pay cycle (Requires every other weekend)

Essential Functions

• Lead other operators during execution of batches and equipment qualifications.
• Execute the production schedule as planned, ensuring equipment/material availability prior to executing the days production.
• Assist Supervisor with resolving issues as they arise.
• Determine root cause and provide solutions.
• Review potential issues/concerns, that may negatively impact the outcome of the successful execution of a batches, to the department Supervisor.
• Monitor line and notify the department supervisor of any action or activity that is a violation of cGMPs, SOP, or Safety, or any outside factor that may impact the safety, strength, efficacy of the product.
• Perform equipment set-up, IQ/OQ/PQ, and commercial batch activities.
• Monitor automatic and semi-automatic equipment to manufacture transdermal products.
• Ensure that all processing equipment, room, scale, and environmental log books are promptly and accurately filled in – recording all activities.
• Work closely with the Technical Writer to generate detailed equipment SOP’s, focusing on set-up, operation, and cleaning.
• Continually monitor the actions of the operators in the course of executing the batch record, to ensure compliance.
• Execute commercial validation batches according to SOPs. Ensure 100% documentation accuracy on all GMP documents, such as bath records, log books, training records, in-process forms.
• Operate complex machines and SOPs to complete Transdermal mixing, coating, converting, pouching and cartooning operations.
• Set-up, run and clean equipment in GMP compliant environment.
• Additional Responsibilities
• R&D and commercial scale-up activities scale-up activities.
• Training New Personnel on SOPs and Equipment

Qualifications

Education

• High School or GED - Required

Work Experience

• 5 years or more of related experience. Manufacturing or GMP environment - Required

Skills And Abilities

• Must be able to understand and communicate in English. Must be able to perform repetitive tasks. - Advanced
• Strong math and mechanical skills. Ability to use computer systems for data entry. - Advanced
• Flexible to work extended hours when required. - Advanced

Specialized Knowledge

• Thorough understanding of the functionality and operational capabilities of all processing equipment in the Transdermal Department.
• Strong expertise in converting (die cutting) and packaging.

Additional Requirements

• Successful completion of an OSHA-compliant Respirator Fit Test is required.

Hourly Rate

The hourly rate for this position ranges from $27.00 to $35.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.

About Us

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [e-mail] . Requests will be handled confidentially and in accordance with applicable laws.