Aseptic Filling Tech

Actalent • Roxbury Township, NJ

404d • $54,080 - $58,240

About The Position

The Aseptic Filling Technician is responsible for the cGMP manufacturing of sterile pharmaceutical dosage forms in a clean room environment. This role involves hands-on work with various manufacturing production equipment and technologies, ensuring compliance with safety policies and Good Manufacturing Practices (GMP). The technician will perform tasks such as equipment setup, weighing materials, manufacturing batches, and filling operations under strict aseptic conditions.

Requirements

• High School diploma with 5 years of Pharma/Biotech Manufacturing Support and 3 years within Clean Room environments.
• Technical certification in a related field is desired.
• Ability to successfully gown into aseptic manufacturing areas.
• Fully sterile gowning experience.
• Knowledge of current Good Manufacturing Practices (GXP) guidelines.
• Mechanical aptitude for operating pharmaceutical manufacturing equipment.

Nice To Haves

• Experience in manual vial inspection, labeling, and packaging.
• Experience in 503B and 503A facility processes.
• Strong organizational and time-management skills.

Responsibilities

• Ensure all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP), and Standard Operating Procedures (SOPs).
• Demonstrate knowledge of current Good Manufacturing Practices (GXP) guidelines.
• Gown up to 10 hours per day, 4 days per week, with gowning and aseptic technique experience.
• Report any accidents, incidents, injuries, or illnesses immediately and notify manager of any hazards, unsafe acts, or conditions in the workplace.
• Prepare for production run by reviewing the production schedule, identifying batch-specific requirements, weighing and measuring ingredients, and adding to mixing equipment.
• Operate pharmaceutical manufacturing equipment, including automated aseptic fill lines, washers, ovens, filter integrity testers, and autoclaves, with mechanical aptitude.
• Complete all necessary cleaning and sanitizing of production equipment and area.
• Accurately complete production documentation and all appropriate logbooks.
• Maintain cleaning logs per SOP requirements.
• Update job knowledge by participating in training opportunities and take ownership of individual training plans.
• Assist with the training of new operators as required and support investigating non-conformance deviations.
• Cross-train and provide support in other areas such as manual vial inspection, labeling, and packaging for both 503B and 503A facility processes.
• Exhibit excellent organization and time-management skills.
• Manage heavy workload and aggressive timelines, prioritize tasks, and work under pressure.
• Possess technical knowledge to operate and troubleshoot all operating equipment with minimal help.
• Review all documentation, including Batch records and Logbooks, in 'Real Time and Right First Time' and demonstrate error-free documentation.
• Immediately report any errors or deviations noticed to management.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Administrative and Support Services
• Education Level: High school or GED
• Number of Employees: 10,001+ employees