WFI System Operator

Position Details:

• Job Title: WFI System Operator

• Location: Gibbstown, NJ (Onsite)

• Salary Range: $25.00 (commensurate with experience)

• Schedule: 1st Shift, 7:00 AM–3:30 PM, Monday–Friday

Position:

WFI System Operator

Works under the guidance of BFS Supervisor and alongside BFS operations in monitoring the Water for Injection (WFI) systems.

Essential Job Functions:

• Operate and monitor WFI, Purified Water (PW), and Pure Steam Generation (PSG) systems, ensuring consistent and compliant water quality.
• Perform minor maintenance tasks and work closely with maintenance teams and outside vendors to perform calibration of equipment, and semi-annual maintenance of WFI system including Reverse Osmosis (RO) units, ozone generator, and filtration systems, to ensure optimal performance.

• Collect water samples to monitor quality parameters, adjusting processes as necessary to maintain compliance with pharmacopeial standards.
• Execute regular system cleaning and sanitization to ensure compliance with all WFI water requirements.
• Maintain accurate records of system operations, maintenance activities, and water quality data, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
• Identify and resolve operational issues promptly, minimizing downtime and ensuring continuous production.
• Work closely with quality assurance, engineering, and production teams to address system-related concerns and contribute to continuous improvement initiatives.
• Perform general housekeeping duties to ensure a safe and organized work environment.
• Maintain the clean room environment by adhering to gowning procedures and cleaning floors and surfaces according to detailed procedures.
• Assist in spill clean-up, following designated procedures as instructed.
• Perform general housekeeping duties to ensure a safe and organized work environment.
• Perform additional duties/tasks as needed or requested by management.

Qualifications:

• Minimum of 2-4 years of experience operating a highly regulated pharmaceutical production facility with clean room operation.
• Proficiency in Microsoft Office.
• Self-starter, strong initiative, dependable and capable of following through with minimal supervision.
• Strong attention to detail, ability to learn complex operations and strong troubleshooting skills.
• Strong documentation skills; proficient in reading and completing daily logs.
• Strong communication skills in English (both written and verbal) to understand and follow procedures, work instructions, and safety guidelines.
• Strong mathematical skills with ability to add, subtract, multiply, and divide various units of measure.
• Ability to work effectively in a fast-paced, team-oriented environment.
• Must be capable of wearing all required protective gear and adhering to all PPE and gowning/garbing procedures.
• Willingness to work flexible hours, including shifts and overtime, as needed.

Desired Skills:

• Relevant certifications in water treatment or system operation are advantageous.
• Previous experience working in a pharmaceutical and clean room environment.
• Knowledge of Good Manufacturing Practices (GMP) and Aseptic manufacturing techniques.

Education/Certifications:

• High school diploma or equivalent required; some college coursework or credits preferred but not required.

Safety:

• Comply with all safety regulations; maintains a safe work environment at all times.
• Adhere to always wearing the proper PPE/Safety equipment.
• Understand and comply with all written safety, health, and environmental procedures.
• Attend all required scheduled Health, Safety and Environmental training sessions.
• Participate in required Health, Safety and Environmental initiatives and programs.
• Perform required administrative functions related to Health, Safety and Environmental functions such as completing forms, checklists, and log sheets.

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Physical Demands: Employee is required to walk; stand; sit; use hands and fingers to manipulate objects, tools, or controls; reach with hands and arms; balance; stoop; bend; kneel and climb; and frequently lift/move up to 50 lbs. In addition, may occasionally be required to maneuver and move 30 to 55-gallon drums and up to 450 pounds utilizing proper ergonomic handling equipment and/or the proper techniques.

• Work Environment: This position is located in a manufacturing facility. Employees frequently work near moving mechanical equipment. Noise intensity level: moderate to loud. Employees may work with hazardous contaminants. This role requires working in a cleanroom environment. Employees must adhere to all Personal Protective Equipment (PPE) and gowning requirements.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.