Production Operator

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. Join our talented workforce, where a commitment to excellence and a customer-focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

About the role

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. This role supports 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).

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 and interpret SOPs to ensure compliance.
• Set up, operate, sanitize, and sterilize equipment and manufacturing areas within a cleanroom setting.
• Prepare, wash, and sterilize vials, perform batch calculations and formulations.
• Sanitize aseptic and controlled areas using specialized solutions and equipment, adhering to sanitization protocols during sterile processing.
• Prepare, sterilize, clean, and decontaminate both dedicated and non-dedicated manufacturing equipment in a cleanroom environment.
• Handle 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.
• Maintain current good documentation practices (cGDP) for all activities.
• Actively participate in training and continuous improvement initiatives to enhance production processes and efficiency.
• Other duties may be assigned.

Requirements

• High school diploma or general education degree (GED).
• Two (2) years related experience in production, manufacturing, and/or cleanroom preferred.
• Ability to read, write, and interpret documents such as safety instructions, standard operating procedures, policies, and manuals.
• Ability to write clearly and communicate effectively.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, decimals, and percentages.
• Ability to draw and interpret bar graphs.
• Demonstrate understanding and effective application of written and oral instruction.
• Skilled in Microsoft Word, Excel, Outlook, and Access.
• Ability to quickly adapt and learn new manufacturing software systems.
• Must pass a background check and drug screen.
• May be required to pass Occupational Health Screening and pre-employment assessment.
• Must be able to obtain and maintain gowning certification and media qualification.
• Must be able to wear a respirator.

Skills

• 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, and participating in safety training programs.
• Demonstrates strong attention to detail.

Benefits

• Generous benefit options (eligible first day of employment).
• Paid training, vacation, and holidays (vacation accrual begins on first day of employment).
• Career advancement opportunities.
• Education reimbursement.
• 401k program.
• Learning platform.
• And more!

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.

• Regular or occasional lifting, pushing, and pulling up to 10 pounds frequently, up to 25 pounds occasionally, and up to 50 pounds infrequently.
• Regular sitting, standing, and reaching, with some roles requiring prolonged periods for each activity.
• Visual acuity, both close and distant, along with depth perception, with or without corrective lenses (employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents).
• Hand and finger dexterity, including typing, manipulating maintenance tools, or operating keypads, switches, and buttons.
• Occasional stooping, kneeling, twisting, crouching, crawling, and balancing.
• Certain roles may involve climbing and working at elevated heights.

Work Environment

The work environment characteristics described here 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.

• Office, manufacturing, or warehouse environment with varying conditions depending on the role.
• Pharmaceutical manufacturing environment is sterile, requiring aseptic gowning and personal protective equipment (nitrile gloves, cleanroom socks, face-shields, safety glasses, aprons, steel-toed shoes, and powered air purifying respirators).
• Exposure to wet and/or humid conditions, confined areas, refrigerator or freezer temperatures, moving mechanical parts, elevated heights, airborne particles, electrical activities, vibration, compressed gases, and cleaning agents.
• Office environment is designed for comfort and productivity, with room temperature settings and conversational noise.