Filling Operator - 2nd Shift

Your Role

• Operate and monitor filling equipment to ensure efficient and accurate production.
• Monitor production equipment while in operation to ensure quality of product.
• Perform cleaning and sanitization of aseptic areas using approved disinfectants and techniques to maintain sterile conditions.
• Maintain strict adherence to aseptic techniques during all operations, including gowning, material transfer, and interventions with controlled environments.
• Understand and apply principles of sterility assurance, including proper handling of sterile components and monitoring of aseptic conditions.
• Demonstrate understanding of Current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines (FDA, EMA, etc.) in an aseptic environment.
• Accurately complete all documentation including but not limited to batch records, logbooks, and deviation reports in compliance with cGMP and data integrity requirements.
• Ensure a high level of safety, quality, and productivity to maintain reliable supply of products to patients.
• Promptly report and assist in investigation of any contamination events or deviations.
• Comply with departmental objectives including improving safety and performance, reducing deviations, and training compliance.
• Perform other duties as assigned by management.

Department Specific / Non-Essential Functions

• Prevent excess waste of product and/or components by operating the equipment in an efficient manner.
• Collaborate with Engineering, Validation, and other departments initiating and implementing programs such as Continuous Improvement (Lean and 5S) and Total Productive Maintenance.
• Cross-training to perform tasks and roles outside of the primary responsibilities.
• Perform other duties as assigned.

Your Background

Education, Experience, and/or Skill:

• High School diploma, GED, or equivalent required.
• 1-2 years' experience as a Production Operator in a pharmaceutical manufacturing environment preferred.
• Knowledge of basic computer skills and Microsoft Office.
• Skilled in the proper handling and use of basic hand tools for routine adjustments and minor maintenance.
• Strong knowledge of aseptic processing, cleanroom standards, and sterile techniques.

Physical Requirements:

• Ability to stand for extended periods of time.
• Must be able to continuously lift a minimum of 50 lbs.
• Ability to operate an electric pallet jack.
• Must be physically able to wear full aseptic gowning, including gloves, mask, and other protective gear, for extended periods while working in a controlled cleanroom environment.

Cognitive Requirements:

• Ability to read and understand military time is required.
• Requires a high degree of manual dexterity to perform tasks using aseptic techniques under restrictive or controlled conditions.
• Strong verbal and interpersonal communication skills.
• Excellent reading comprehension and attention to detail for interpreting batch records and SOPs.
• Strong mathematical aptitude for accurate measurements and calculations.
• Mental and visual acuity for production of quality product.
• Highly skilled in problem-solving and diagnostic abilities.
• Demonstrates initiative and sound decision making while working effectively both independently and as part of a team.
• Demonstrates strong attention to detail in all tasks to ensure accuracy and compliance.