The hours for this role are 3pm - 1:30am

Job Summary

The Production Sterilization Specialist will be responsible for conducting labeling, packaging, and production support activities to support commercial manufacturing. Under the direction of the Production Supervisor/Team Leader, the Production Support Associate will work hands-on under ISO7, ISO8, and other classified areas with various manufacturing production equipment and technologies. Daily responsibilities vary, including operating cleaning machines and preparing supplies for manufacturing by cleaning and disinfecting. 

Core Responsibilities

• Ensures that all work is carried out in compliance with company Safety Policies, current Good Manufacturing Practices (cGMP), and Standard Operating Procedures (SOPs).
• Wears proper personal protective equipment and follows aseptic procedures when gowning, de-gowning, and working in sterile and controlled areas.
• Reports any accidents, incidents, injuries, or illnesses immediately and notifies the manager of any workplace hazards, unsafe acts, or conditions.
• Accurate completion of product documentation and all appropriate logbooks. Maintains cleaning logs per SOP requirements.
• Knowledge of current Good Manufacturing Practices (cGMP) guidelines.
• Excellent organization and time-management skills are required. Must promptly manage a heavy workload and aggressive timelines, prioritize, and work under pressure.
• Cleaning, sanitizing, and disinfection of equipment and components required for production. 
• Works with the Warehouse Department to ensure all components are available ahead of time for production. 
• Completes all necessary cleaning and sanitizing of production equipment and area.
• Stages material for production use.
• Operation of cleaning equipment including but not limited to Autoclave, Fedegari, and Depyrogentation oven.
• Performs calibration of check weighing.

Qualifications & Requirements

• High School Diploma or equivalent work and education in a related field are required.
• 1-3 years of experience working in the pharmaceutical industry and within aseptic clean room environments.
• Demonstrated ability to successfully gown into aseptic manufacturing areas.
• Ability to handle sensitive information with a high degree of confidentiality.
• Ability to work in a fast-paced environment while demonstrating excellent time management and organization skills.
• Proficient in using standard Microsoft Office software products, including Excel, Outlook, and Word.
• Strong organizational skills with the proven ability to prioritize.
• Works with a sense of urgency while engaging and listening to experts.

Job Summary 

 HOURS - 3:00PM - 1:30AM

The Maintenance Mechanic will be responsible for maintaining manufacturing, filling equipment, facilities and utilities following Standard Operating Procedure. Under the direction of the Facilities and Maintenance Manager, the Maintenance Mechanic will support operations and other departments for day-to-day manufacturing activities working within classified areas on a variety of manufacturing production equipment and technologies. Daily responsibilities vary and include maintenance of HVAC, Water System, Manufacturing and Filling Equipment.  

Core Responsibilities 

• Ensures that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs) 

• Responsible for maintaining all manufacturing equipment including formulation, filling and packaging equipment, and plant utility systems including boilers, air compressors, heating, ventilation and air conditioning systems (HVAC), Water for Injection (WFI), and general upkeep of the physical plant including clean rooms. 

• Perform manufacturing and facility equipment maintenance, installations and repairs as needed including but not limited to electrical, plumbing, and light construction. 

• Assist with development and documentation of preventative maintenance and calibration program for production equipment including clean room and utilities. 

• Document preventive maintenance, reactive maintenance and calibration events on company deployed computerized maintenance management system (CMMS). 

• Coordinate services with outside vendors for calibration and routine maintenance. 

• Perform execution of equipment installation and qualification. 

• Deploy 5S strategies in the setting up and maintenance of spare parts inventory utilizing CMMS software. 

• Monitor facilities and manufacturing operating equipment daily, troubleshooting problems and inefficiencies and recommending possible solutions. 

• Supports continuous improvement by completing work on time, identifying potential issues, and driving to improve work processes and procedures relative to manufacturing and/or filling and packaging equipment. 

• Provide after-hours support and/or weekend emergency service. 

• Perform continuous training assignments within the allotted time schedule. 

Qualifications & Requirements 

• Must have experience in a cGMP regulated environment and have worked in a medical device or pharmaceutical manufacturing facility. 

• Minimum of 2 - 3 years previous experience in a medical device or pharmaceutical manufacturing preferably in a clean room environment. 

• Must be familiar with machine controls including Programmable Logic Controllers (PLCs), relay logic, and operator interfaces. 

• Must be comfortable working on and troubleshooting low voltage (DC) as well as high voltage (120VAC) systems. 

• Must be familiar with plant utility systems compressors and HVAC. 

• Strong technical ability and mechanical aptitude to troubleshoot and repair equipment malfunctions. 

• Must be able to provide after-hours support and/or weekend emergency service support. 

• Demonstrated ability to effectively maintain, troubleshoot, and repair industrial equipment involving technical and mechanical issues (i.e. equipment adjustments, parts replacement). 

• Requires a demonstrated mechanical and technical aptitude in order to problem-solve effectively. 

• Ability and willingness to work and participate effectively in a team environment.  

• Ability and willingness to maintain accurate and factual hard copy and electronic records. 

• Attention to detail, safety, quality and customer requirements. 

• Ability to effectively communicate verbally and in writing to peers and management. 

• Ability to read information and apply what is described in the reading material to situations that may contain several details or describe processes involving several steps. 

• Demonstrate high level of personal motivation and initiative. 

Position Type  

• On-Site 

Travel 

• None 

Job Summary 

 HOURS ARE 9:00 am - 7:30pm

The Production Visual Inspection Technician Level 1 will be responsible for conducting visual inspections of vials for cosmetic and physical defects to support manufacturing. Under the direction of the Production Supervisor, the Visual Inspector will work hands on, under ISO7, ISO8 and other classified areas with a variety of manufacturing production equipment and technologies. Dally responsibilities vary. 

Core Responsibilities 

• Ensures that all work Is carried out in compliance with company Safety Policies, current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). 

• Wears proper personal protective equipment and follows aseptic procedures when gowning, de-gowning and working in the sterile and controlled areas. 

• Reports any accidents, Incidents and Injuries or Illnesses immediately and notifies manager of any hazards, unsafe acts or conditions in the workplace. 

• Accurate completion of production documentation and all appropriate logbooks. Maintains cleaning logs per SOP requirements. 

• Knowledge of current Good Manufacturing Practices (cGMP) guidelines. 

• Excellent organization and time-management skills required. Must be able to manage heavy workload and aggressive timelines in a timely manner, prioritize and work under pressure. 

• Performs visual Inspection of vials for cosmetic and physical defects. 

• Responsible for classification of defects observed during the Inspection as per related procedures. 

• Must have close visual acuity to notice errors and/or defects and attention to detail. 

• Inspector qualification for visual Inspection of injectables for a length of 8 hours. 

• Inspector qualification for visual inspection of solution products. 

• Manual dexterity and the ability to perform repetitive motions with accuracy are required, 

• Report abnormalities and deviations in a timely and accurate manner, 

• Contributes to Quality activities such as supporting investigations, corrective actions, and area walk-throughs. 

• Ability to work as part of a high-performing team and collaborate effectively with staff. 

Qualifications & Requirements 

• High School Diploma or equivalent work and education in a related field, required, 

• 1-2 years of visual Inspection experience. 

• Ability to work Independently. 

• Ability to handle sensitive Information with a high degree of confidentiality. 

• Basic math skills 

• Proficient In the use of standard Microsoft Office software products, including Excel, Outlook, Word. 

• Strong organizational skills with the proven ability to prioritize, 

• Works with a sense of urgency, while engaging and listening to experts. 

• (20/20) vision with corrections. 

Position Type  

• On-Site 

Travel 

• None