Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of Fifteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.

Role Summary

Lupin is a global pharmaceutical consumer product company, with an excellent work environment and benefits. The Production Operator will assist in the manufacturing, labelling and packaging of Medical Drug products.

Essential Duties and Responsibilities

• Verifies dispensed raw materials for batches, stages components and assemble production equipment for each batch.
• Performing equipment daily usage checks and filling out appropriate logbooks.
• Follows and understands all Batch Record and SOP instructions while completing all relevant documentation as required.
• Documents all operational parameters and steps performed in the batch record for manufacturing and packaging.
• Weighing and documenting the weight of components in-process and /or finished product.
• Performs standard in-process testing procedures on daily basis.
• Monitoring all production lines for accuracy, stability, conformity and product defects.
• Assembles, stages and distributes components for the manufacturing and packaging of batches.
• Places product into shipper boxes and attaching shipping labels.
• Documents and disposes of all production waste in dedicated waste containers at the end of each batch.
• Palletizes and transports finished goods around the facility using carts or pallet jacks to include in and out of refrigerated cooler.
• Cleans production rooms and equipment as needed while documenting in appropriate logbooks.
• Supports Laboratory and QA operations if needed.
• Works safely as a member of a team to achieve all outcomes.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance, and safety requirements.
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
• Performs Compounding activities to include delicate Equipment Setup.
• Performs in-process setup and trouble shoot minor equipment issues.
• Perform in-process adjustments to equipment to maintain operating parameters.
• Assist in coaching and mentoring Level I operators if needed.
• All other relevant duties as assigned.

Education and Experience

• High school diploma or general education degree (GED)
• Minimum of six months experience and/or training; or equivalent combination of education and experience within a Production cGMP Environment.
• Knowledge of FDA, cGMP, GDP and SOPs related to job requirements.
• Ability to read and interpret documents in English such as safety rules, Standard Operating Procedures, batch records, and cleaning procedures.
• Proficient in English to sign and complete batch record documentation.
• Ability to speak and understand English effectively.
• Ability to add, subtract, multiply and divide using different units of measure to include averages of whole numbers, common fractions, and decimals.
• Ability to apply common sense thinking and understanding to carry out detailed written instructions.

Lupin  is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.

Physical Requirements and Working Conditions: 

While performing the duties of this job, the employee is regularly required to sit, stand, walk, stoop, kneel, crouch, or crawl for a minimum of 8 hours. Employee will be subject to temperatures ranging from 2°C to 25°C on a daily basis and must be able to transport product in and out of refrigerated cooler within those temperature ranges. Employee must frequently lift and/or move up to 50 pounds. While performing the duties of this job, the employee is regularly exposed to moving mechanical parts. The employee may be exposed to fumes airborne particles, toxic and/or caustic chemicals (PPE Provided). The noise level in the work area may be loud at certain times. The employee will be required at times to wear a full-face respirator and/or TYVEK or TYCHEM jumpsuits during cleaning operations, as well as eye protection, hearing protection, and other personal protective equipment (PPE) as required. The employee may be required to work additional hours from time to time, including weekends (O/T). Shift hours are subject to change due to operational needs.

Search Firm Representatives Please Read Carefully 

Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails