Aseptic Technician

Join a dynamic team involved in aseptic manufacturing operations, performing critical tasks such as aseptic compounding, formulation preparation, sterile filtration, filling, and visual inspections according to approved batch records and SOPs. This role requires a keen attention to detail and a commitment to maintaining the highest standards of sterility and cleanliness within ISO classified cleanroom environments.

Responsibilities

• Execute aseptic compounding, formulation preparation, sterile filtration, filling, and visual inspection activities following approved batch records and SOPs.
• Prepare and verify raw materials, components, and equipment before manufacturing activities.
• Operate and monitor aseptic filling equipment, pumps, filtration systems, and related production equipment.
• Perform vial, syringe, or IV bag filling operations in compliance with validated manufacturing processes.
• Ensure proper container closure integrity and visual inspection requirements during production.
• Adhere to cleanroom gowning procedures, personnel qualification requirements, and aseptic behavior standards.
• Maintain compliance with contamination control strategies and sterility assurance practices.
• Perform equipment setup, cleaning, sanitization, and basic troubleshooting activities.
• Complete Batch Production Records (BPRs) accurately and in accordance with ALCOA+ data integrity principles.
• Report manufacturing deviations and participate in investigations related to manufacturing events.

Requirements

• Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or related field preferred.
• 1 to 3 years of experience in aseptic pharmaceutical manufacturing, sterile compounding, or sterile injectable production.
• Experience in ISO classified cleanrooms and aseptic processing environments.
• Knowledge of CGMP regulations, FDA 503B requirements, USP <797>, USP <71>, USP <85>, and Annex 1 guidance.
• Understanding of contamination control principles and sterile manufacturing processes.

Skills

• Experience with aseptic filling operations, sterile filtration, and manufacturing documentation.
• Strong understanding of contamination control principles and sterile manufacturing processes.

Work Environment

• Work in an FDA-registered 503B outsourcing facility in Albany, NY, specializing in sterile compounded medications for critical care settings.
• Operate under strict current Good Manufacturing Practices (cGMP) and regulatory oversight.
• Collaborate closely with Quality Assurance, Quality Control, Environmental Monitoring, Facilities, Engineering, Validation, and Compliance Teams.
• Garbing and PPE are required in a cleanroom environment.

Schedule

Monday to Friday from 9 am to 5 pm.

Pay

The pay range for this position is $30.00 - $50.00/hr. Individual compensation offered within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, and internal equity.

Benefits

Eligibility requirements apply to some benefits and may depend on job classification and length of employment. Benefits are subject to change and may include:

• Medical, dental, and vision insurance
• Critical Illness, Accident, and Hospital insurance
• 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)

About the Role

• This is a Contract to Hire position based in Colonie, NY.
• Fully onsite position.