Aseptic Technician
- New Brunswick, NJ
- $28.00-30.00 per hour
- Contract
- Full-time
Job DescriptionThe Aseptic Technician will be responsible for supporting the production of sterile injectable pharmaceutical products in accordance with cGMP, FDA, and quality standards. This role involves operating, cleaning, and maintaining aseptic manufacturing equipment while adhering to strict safety, quality, and documentation practices. The technician may be assigned to various activities within Granulation, Blending, Compression, Coating, Dispensing, Sterile Manufacturing, or Technical Service.Responsibilities
- Follow all policies, SOPs, and regulatory requirements for pharmaceutical manufacturing.
- Perform aseptic gowning and operate within classified cleanroom environments (ISO 5–7).
- Set up, clean, and operate production equipment including autoclaves, depyrogenation tunnels, sterile filling machines, and lyophilizers.
- Manufacture products according to cGMP and GDP standards, ensuring accuracy and compliance in all documentation.
- Conduct inventory checks and maintain adequate consumable stock levels.
- Partner with Quality Assurance for line clearance and with Engineering for equipment/facility issues, ensuring timely work order follow-up.
- Participate in training programs; serve as a trainer/mentor for new operators as assigned.
- Support deviation investigations, CAPAs, and continuous improvement initiatives.
- 2-3 years of Aseptic Gowning experience in sterile processing.
- Pharma GMP experience in Compounding, Mixing, Blending, and Compressing.
- Strong documentation skills.
- Be alert and present, with abilities in sterilization, visual inspection, production, cGMP, assembly, and filling.
- High school diploma or equivalent; further technical/scientific education preferred.
- Experience in sterile pharmaceutical manufacturing strongly desired; sterile injectable experience preferred.
- Knowledge of pharmaceutical manufacturing equipment and aseptic processing principles.
- Ability to troubleshoot technical issues in assigned production areas.
- Strong communication skills with the ability to work effectively across departments.
- Flexibility to work shifts, weekends, and overtime as required.
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
- 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)