Aseptic Technician
Aerotek, Ridgefield, NJ, United States
Aseptic Technician
Location: Ridgefield, NJ
Pay: $25-$30 hour
Shift: 12:00 PM - 8:00 PM Monday - Friday
Job Description
The Aseptic Technician supports intermediate aseptic bulk manufacturing and filling operations for hyaluronic acidbased and other pharmaceutical and medical device products in a cGMP-regulated environment. This role performs aseptic gown qualifications, participates in media simulations, executes formulation, filling, and packaging activities, and maintains accurate batch records and documentation. The technician also cleans and sanitizes process equipment and classified spaces, assists with validation and environmental monitoring, and works a primarily second-shift schedule with flexibility for extended hours and weekends based on production needs.
Responsibilities
Perform aseptic gown qualification and maintain gown qualification at scheduled intervals in alignment with regulatory requirements.
Participate in aseptic media simulations at scheduled intervals to support regulatory and process validation requirements.
Execute production operations related to intermediate aseptic bulk manufacturing, including collection and extraction of hyaluronic acid (HA), HA gel manufacturing, buffer and saline production, and aseptic fluids/bulk and gel processing.
Perform filling operations for pharmaceutical and medical device products, ensuring adherence to aseptic techniques and cGMP standards.
Independently perform routine tasks in formulation, filling, and packaging operations based on business needs.
Maintain complete and accurate batch record documentation and logs in compliance with corporate policies and regulatory agency requirements.
Serve as a witness for routine unit operational tasks and sign batch records to verify accurate execution of procedures.
Prepare production equipment, filters, and related materials required for manufacturing activities.
Clean and sanitize process equipment, rooms, and classified production areas according to established SOPs and schedules.
Perform routine daily and weekly cleaning of the manufacturing area to maintain a controlled and compliant environment.
Conduct product sampling, environmental monitoring, and related quality support activities as directed.
Assist in process and system validation activities, including documentation and execution of validation protocols.
Ensure all work complies with GMPs, SOPs, and regulatory requirements, and complete all required cGMP training.
Use good documentation practices to record work accurately, legibly, and in real time.
Identify issues during operations, troubleshoot within defined procedures, propose solutions, and keep leads and management informed.
Support health, safety, and environmental (HSE) initiatives by following all site HSE policies and local HSE regulations.
Complete all required HSE training, report all accidents and incidents, and support investigations in areas of responsibility.
Ensure timely closure of HSE-related actions assigned to the department.
Work safely with process equipment and materials, including transferring heavy vessels on wheels and moving autoclave racks on wheels.
Operate effectively while wearing aseptic gowning for approximately 80% of the shift, maintaining aseptic discipline at all times.
Handle materials and products by offloading from carts to pallets and moving transfer carts in and out of the manufacturing area.
Maintain a high level of attention to detail while standing for extended periods and performing repetitive tasks.
Collaborate with team members in a fast-paced manufacturing environment while also completing tasks independently as required.
Essential Skills
Experience with aseptic manufacturing operations including bulk manufacturing and filling.
Minimum 2 years of related experience in pharmaceutical manufacturing.
At least 2 years of experience working in a GMP-regulated environment.
Strong knowledge of cGMP and regulatory compliance requirements.
Ability to work in an aseptic environment while fully gowned for approximately 80% of the shift.
Proficiency in cleaning and sanitizing process equipment, rooms, and classified manufacturing spaces.
Ability to perform routine daily and weekly cleaning of manufacturing areas in accordance with SOPs.
Capability to maintain accurate batch records and logs using good documentation practices.
Ability to follow GMPs, SOPs, and established procedures with high attention to detail.
Physical ability to stand for several hours at a time, bend, squat, reach, and perform repetitive tasks.
Ability to lift, push, and pull various weights, including moving heavy vessels on wheels and autoclave racks.
Ability to offload products from carts to pallets and move transfer carts in and out of the manufacturing area.
Ability to work safely in confined spaces approximately 12 hours per week as needed.
Capability to complete tasks and training in a cGMP environment and apply that training consistently.
Job Type & Location
This is a Contract position based out of Ridgefield, NJ.
Pay and Benefits
The pay range for this position is $25.00 - $30.00/hr.
Eligibility requirements apply to some benefits and may depend on your job 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)
Workplace Type
This is a fully onsite position in Ridgefield, NJ.
Application Deadline
This position is anticipated to close on Apr 30, 2026.
Location: Ridgefield, NJ
Pay: $25-$30 hour
Shift: 12:00 PM - 8:00 PM Monday - Friday
Job Description
The Aseptic Technician supports intermediate aseptic bulk manufacturing and filling operations for hyaluronic acidbased and other pharmaceutical and medical device products in a cGMP-regulated environment. This role performs aseptic gown qualifications, participates in media simulations, executes formulation, filling, and packaging activities, and maintains accurate batch records and documentation. The technician also cleans and sanitizes process equipment and classified spaces, assists with validation and environmental monitoring, and works a primarily second-shift schedule with flexibility for extended hours and weekends based on production needs.
Responsibilities
Perform aseptic gown qualification and maintain gown qualification at scheduled intervals in alignment with regulatory requirements.
Participate in aseptic media simulations at scheduled intervals to support regulatory and process validation requirements.
Execute production operations related to intermediate aseptic bulk manufacturing, including collection and extraction of hyaluronic acid (HA), HA gel manufacturing, buffer and saline production, and aseptic fluids/bulk and gel processing.
Perform filling operations for pharmaceutical and medical device products, ensuring adherence to aseptic techniques and cGMP standards.
Independently perform routine tasks in formulation, filling, and packaging operations based on business needs.
Maintain complete and accurate batch record documentation and logs in compliance with corporate policies and regulatory agency requirements.
Serve as a witness for routine unit operational tasks and sign batch records to verify accurate execution of procedures.
Prepare production equipment, filters, and related materials required for manufacturing activities.
Clean and sanitize process equipment, rooms, and classified production areas according to established SOPs and schedules.
Perform routine daily and weekly cleaning of the manufacturing area to maintain a controlled and compliant environment.
Conduct product sampling, environmental monitoring, and related quality support activities as directed.
Assist in process and system validation activities, including documentation and execution of validation protocols.
Ensure all work complies with GMPs, SOPs, and regulatory requirements, and complete all required cGMP training.
Use good documentation practices to record work accurately, legibly, and in real time.
Identify issues during operations, troubleshoot within defined procedures, propose solutions, and keep leads and management informed.
Support health, safety, and environmental (HSE) initiatives by following all site HSE policies and local HSE regulations.
Complete all required HSE training, report all accidents and incidents, and support investigations in areas of responsibility.
Ensure timely closure of HSE-related actions assigned to the department.
Work safely with process equipment and materials, including transferring heavy vessels on wheels and moving autoclave racks on wheels.
Operate effectively while wearing aseptic gowning for approximately 80% of the shift, maintaining aseptic discipline at all times.
Handle materials and products by offloading from carts to pallets and moving transfer carts in and out of the manufacturing area.
Maintain a high level of attention to detail while standing for extended periods and performing repetitive tasks.
Collaborate with team members in a fast-paced manufacturing environment while also completing tasks independently as required.
Essential Skills
Experience with aseptic manufacturing operations including bulk manufacturing and filling.
Minimum 2 years of related experience in pharmaceutical manufacturing.
At least 2 years of experience working in a GMP-regulated environment.
Strong knowledge of cGMP and regulatory compliance requirements.
Ability to work in an aseptic environment while fully gowned for approximately 80% of the shift.
Proficiency in cleaning and sanitizing process equipment, rooms, and classified manufacturing spaces.
Ability to perform routine daily and weekly cleaning of manufacturing areas in accordance with SOPs.
Capability to maintain accurate batch records and logs using good documentation practices.
Ability to follow GMPs, SOPs, and established procedures with high attention to detail.
Physical ability to stand for several hours at a time, bend, squat, reach, and perform repetitive tasks.
Ability to lift, push, and pull various weights, including moving heavy vessels on wheels and autoclave racks.
Ability to offload products from carts to pallets and move transfer carts in and out of the manufacturing area.
Ability to work safely in confined spaces approximately 12 hours per week as needed.
Capability to complete tasks and training in a cGMP environment and apply that training consistently.
Job Type & Location
This is a Contract position based out of Ridgefield, NJ.
Pay and Benefits
The pay range for this position is $25.00 - $30.00/hr.
Eligibility requirements apply to some benefits and may depend on your job 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)
Workplace Type
This is a fully onsite position in Ridgefield, NJ.
Application Deadline
This position is anticipated to close on Apr 30, 2026.