PRODUCTION SUPPORT OPERATOR, FCG (B SHIFT)

The Production Support Operator supports the timely manufacturing (i.e., vial prep, fill line operation, lyophilizer load / unload and vial sealing) of parenteral products according to Current Good Manufacturing Practice (cGMP) in an aseptic environment. Responsibilities encompass setting up, operating, sanitizing and sterilizing equipment and manufacturing areas in a cleanroom setting. Tasks include preparing, washing, and sterilizing vials, as well as completing batch calculations and formulations. Additionally, the operator ensures compliance with all relevant regulations and procedures, maintains current good documentation practices (cGDP) for all activities, and participates in training and continuous improvement initiatives to enhance production processes and efficiency. The position also involves sanitizing aseptic and controlled areas using specialized solutions and equipment, following sanitization protocols during sterile processing of equipment, and complying with Standard Operating Procedures (SOPs) for all sanitization and documentation tasks.

Essential Duties and Responsibilities :

• Follow Drug Enforcement Administration (DEA) regulations during controlled substance formulations
• Prepare and sterilize equipment for clean rooms, product compounding, and filling according to the preparation list, to include disassembly and assembly
• Record all procedures in logbooks and complete / correct batch records according to cGDP
• Sanitize aseptic / controlled production areas to ensure microbial contamination is reduced to a safe level on inanimate surfaces
• Pre and post test filters
• Read / interpret SOPs to ensure compliance
• Maintain up to date trainings
• Other duties may be assigned

Education and Experience :

Language Skills :

Ability to read, write and interpret documents such as, but not limited to, safety instructions, standard operating procedures, policies, and manuals. Ability to write clearly and communicate effectively.

Mathematical Skills :

Ability to add, subtract, multiply and divide into all units of measure, using whole numbers, common fractions, decimals and percentages. Ability to draw and interpret bar graphs.

Reasoning Ability :

Ability to demonstrate understanding and effective application of written and oral instruction.

Computer Skills :

Skilled in Microsoft Word, Excel, Outlook, and Access. Ability to quickly adapt and learn new manufacturing software systems.

Other Skills and Abilities :

Other Qualifications :

Must pass a background check

Must pass a drug screen

May be required to pass Occupational Health Screening

Must pass pre-employment assessment

Must be able to obtain and maintain gowning certification

Must be able to obtain and maintain media qualification

Must be able to wear a respirator

Physical Demands :

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The essential physical demands will vary for each Curia position.

All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each positions physical requirements. Certain roles may involve climbing and working at elevated heights as well.

Work Environment :

The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.

The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.

The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and / or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.

The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.

Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection.

All environments may be subject to working with or being exposed to cleaning agents.