Summary:

The Wash & Prep Production Support Operator facilitates the timely preparation of filling equipment and components in the manufacture of parenteral products according to Current Good Manufacturing Practice (cGMP) in an aseptic environment. Responsibilities include prepping, sterilizing, cleaning, and decontaminating dedicated and non-dedicated manufacturing equipment in a cleanroom setting. They also sanitize controlled areas using specialized solutions and equipment, perform sterile processing of equipment according to sanitization procedures and complete all sanitization and documentation in accordance with Standard Operating Procedures (SOPs). Additionally, the operator ensures compliance with all relevant regulations and procedures, maintains current good documentation practices (cGDP) of all activities performed, and participates in training and continuous improvement initiatives to enhance production processes and efficiency.

 Essential Duties and Responsibilities: 

• Prepare and sterilize equipment for clean rooms, product compounding, and filling according to the preparation list, which includes disassembly/assembly tasks
• Load and unload steam sterilizers and washers
• Prepare and weigh stoppers and plungers according to proper diagrams and instructions 
• Record all procedures in logbooks and complete/correct batch records according to cGDP 
• Sanitize 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:

• High school diploma or general education degree (GED)
• Two (2) years related experience in production, manufacturing, and/or cleanroom preferred

Supervisory Responsibilities: 

This role does not have supervisory responsibilities.

Language Skills: 

Ability to read 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. 

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.