Job Title: Aseptic Filling Tech

Job Description

The Sterile Production Technician will be responsible for conducting cGMP manufacturing of sterile pharmaceutical dosage forms for commercial manufacturing. Under the direction of the Production Supervisor, the Sterile Production Technician will work hands-on, under ISO7 and ISO5 areas, with a variety of manufacturing production equipment and technologies. Daily responsibilities vary and include production equipment setup, weighing of materials, manufacturing of batches, sterilization of products, submitting samples, and performing filling operations under ISO5 environment.

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.

Essential Skills

• 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.

Additional Skills & Qualifications

• Experience in manual vial inspection, labeling, and packaging.
• Experience in 503B and 503A facility processes.
• Strong organizational and time-management skills.
• Ability to manage heavy workload and aggressive timelines.
• Capability to prioritize tasks and work under pressure.

Work Environment

Various clean rooms (ISO 5 & 7). Work schedule is Monday to Thursday from 8 am to 6:30 pm.

Pay and Benefits

The pay range for this position is $26.00 - $28.00

• 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)

Workplace Type

This is a fully onsite position in Ledgewood,NJ.

Application Deadline

This position will be accepting applications until Dec 6, 2024.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $26 - $28