The Production Support Operator ensures compliance with cGMP standards, maintains accurate and thorough documentation, and contributes to ongoing training and process improvement efforts to optimize production efficiency and product quality. Responsibilities are comprised of supporting the timely manufacturing of parenteral products, including vial preparation, fill line operation, lyophilizer loading/unloading, and vial sealing, all conducted in an aseptic environment according to Current Good Manufacturing Practice (cGMP). The role encompasses setting up, operating, sanitizing, and sterilizing equipment and manufacturing areas within a cleanroom setting. Key tasks include preparing, washing, and sterilizing vials, performing batch calculations and formulations, and ensuring compliance with all relevant regulations and procedures. The operator maintains current good documentation practices (cGDP) for all activities and actively participates in training and continuous improvement initiatives to enhance production processes and efficiency. Responsibilities also extend to sanitizing aseptic and controlled areas using specialized solutions and equipment, adhering to sanitization protocols during sterile processing, and strictly following Standard Operating Procedures (SOPs) for all sanitization and documentation tasks. Additionally, the role involves the preparation, sterilization, cleaning, and decontamination of both dedicated and non-dedicated manufacturing equipment in a cleanroom environment. The operator handles the compounding or formulation of drug solutions, using costly raw materials and hazardous chemicals, while adhering to safety protocols and wearing appropriate personal protective equipment.

Essential Duties and Responsibilities:

• Adhere to Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), and proper aseptic techniques to ensure the production of sterile, high-quality products

• Assemble and operate automated filling and sealing equipment aseptically

• Accurately document and review production paperwork to ensure clarity and compliance

• Perform in-process inspections or pre-inspections of vials as required

• Maintain and stock gowning materials to ensure proper gowning procedures

• Clean and sanitize work areas to maintain a sterile manufacturing environment

• Collaborate with peers to provide mutual training and support under the guidance of Production Management

• Read/interpret SOPs to ensure compliance

• Maintain up to date trainings

• Other duties may be assigned

  Education and Experience:

• High school diploma or general education degree (GED)

• Two (2) years related experience in production, manufacturing, and/or cleanroom preferred

  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:

• Fosters a collaborative and positive work environment

• Champions change

• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.

• Demonstrates strong attention to detail

  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 position’s 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.