Description

Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations.  Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success.  Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas. 

Innovating every day.™

Basic Purpose:

Ensure timely maintenance of all packaging equipment and assist direct supervisor with the training of associates.

Essential Functions and Responsibilities

• Responsible for the maintenance, changeover, and set-up of Packaging equipment to ensure production goals are met.
• Responsible for ensuring all Packaging equipment is operating while meeting all safety requirements.
• Responsible to effectively communicate all major line breakdowns and changeover information to direct supervisor and shift supervisor.
• Responsible to effectively communicate all necessary information (Line breakdowns, changeovers, inventory, etc.) to the Lead Mechanic and mechanics on assigned shift and the mechanics on the on-coming shift.
• Must have the ability to work independently when required and/or as a team when required.
• Must be willing to work weekends and overtime, as needed.
• Ability to troubleshoot all Packaging equipment to ensure productivity is maintained.
• Must document all repairs and replacement in the appropriate line logbooks to maintain equipment history.
• Responsible for evaluating the need for spare parts and adding to MRO inventory and ensuring MRO has all the necessary information to maintain inventory levels for all Packaging equipment.
• Responsible for performing all the required Preventive Maintenance’s (PM) on all Packaging equipment.
• Ability to deal effectively and professionally with contractors and vendors.
• Must be able to comprehend Packaging equipment operating manuals.
• Must be able to read and follow basic electrical and pneumatic schematics.
• Demonstrate the ability to initiate GMP documents including Change Controls, Engineering Change Controls, and Out Of Service forms, when required.
• Responsible for assisting other mechanics with troubleshooting, changeover, and set-ups when possible to increase product output.
• Responsible for performing any activities assigned by direct or designated supervisor.
• Must have the willingness to take on special projects that have been identified as process improvements for the Packaging department.
• Must be aware of and abide to all company policies at all times and in all company premises and report any deviations from Standard Operating Procedures (SOP).
• Must perform all required activities while adhering to all the current Good Documenting Practices (cGDP) and current Good Manufacturing Practices (cGMP).
• Other duties assigned by management.

Education/Training/Work Experience

• High School diploma or equivalent preferred and/or relevant work experience
• Previous mechanical/electrical maintenance/shop experience with lathe, mill and welding desired.

Specialized Knowledge and Skills

• Ability to solve complex technical problems and possess strong mechanical aptitude.
• Basic Tool Capabilities – hand tools, measuring devices, power tools, basic shop tools such as bearing press, drill press, saws and pipe threader.
• Must have basic computer skills.
• Ability to communicate effectively by use of two-way radios, e-mail, texts, phone, etc.
• Ability to troubleshoot, perform changeovers and set-ups on multiple lines.
• Demonstrates initiative, ownership, and problem-solving skills to make line improvements in the areas of quality, efficiency, and safety.
• Basic electrical knowledge and the ability to troubleshoot basic electrical circuitry.
• Basic pneumatic and hydraulic knowledge and ability to troubleshoot.

Equipment and Applications

• Various pieces of Packaging equipment, including but not limited to fillers, cartoners, bundlers, case packers, palletizers, collators, applicator feeders, tube feeders, bottle unscramblers, induction sealers, re-torquers, check weighers, scales, pumps, conveyors, tape machines, motorized and manual pallet jacks, pallet lifts

Work Environment and Physical Demands (List required PPE’s)

• Required to wear proper GMP gowning and PPE prior to entering GMP areas.
• GMP gowning includes lab coat with sleeves worn at wrist level and all snaps connected, hairnet, beard cover (if applicable), procedure mask, and gloves, both are required when working over any open product or componentry
• Safety Glasses must be worn while in GMP areas, Labs, and Maintenance shop.
• Ability to withstand repetitive work
• Ability to stand for long periods of time with a moderate amount of bending and/or stretching
• Ability to lift up to and including 50 lbs on a regular basis
• Ability to pay close attention to detail while performing required duties
• Ability to adhere to all Lock Out/Tag Out procedures and machine guarding procedures.

Equal Opportunity Employment

Providing “equal employment opportunity” is one of the most important people policies of Cosette Pharmaceuticals, Inc. Our goal is to do all that we realistically can to provide genuine equal employment opportunity to applicants and employees in all phases of our operation. It is the policy of this Company that there shall be no discrimination with respect to employment, or any of the terms and conditions of employment, because of an individual’s race, creed, religion, color, national origin, citizenship, ancestry, age, gender identity or expression, affectional or sexual orientation, marital status, domestic partnership, familial status, atypical hereditary cellular or blood trait, disability (including AIDS and HIV infection), genetic information, liability for service in the United States armed forces or any other legally protected status. The Company is dedicated to ensuring that all employment decisions are in accordance with these principles of equal employment opportunity.