Production Operator

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.

Responsibilities

• 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).
• Ensures compliance with all relevant regulations and procedures.
• Prepares, washes, and sterilizes vials, performs batch calculations and formulations.
• Cleans and sanitizes work areas to maintain a sterile manufacturing environment.
• Collaborates with peers to provide mutual training and support under the guidance of Production Management.
• Prepares, sterilizes, cleans, and decontaminates both dedicated and non-dedicated manufacturing equipment in a cleanroom environment.
• 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.

Requirements

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

Qualifications

• 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.
• 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.
• 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.

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, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
• 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!

Pay

TBD

Schedule

TBD