Aseptic Technician
hace 4 días
Ridgefield
Job DescriptionJob Title: Aseptic Technician Job Description The Aseptic Technician supports intermediate aseptic bulk manufacturing and filling operations for hyaluronic acid–based 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, • 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 1–2 hours per week as needed., • Capability to complete tasks and training in a cGMP environment and apply that training consistently., • Ability to work effectively both independently and as part of a team., • Good documentation skills and strong attention to detail., • Ability to receive instructions on assignments and work with some supervision while building independence., • Basic computer skills to support documentation and training requirements.Additional Skills & Qualifications, • Experience with aseptic manufacturing operations including bulk manufacturing and filling., • Hands-on experience with collection and extraction of hyaluronic acid (HA) and HA gel manufacturing., • Familiarity with buffer and saline production, intermediate bulk manufacturing, filling, inspection, and packaging for medical device and pharmaceutical products., • Experience performing environmental monitoring and product sampling in a controlled environment., • Demonstrated ability to troubleshoot operational issues, propose practical solutions, and communicate effectively with leads and management., • Proactive approach to health, safety, and environmental compliance, including timely completion of HSE training and actions., • Comfort working in a structured, procedure-driven environment with high quality and compliance expectations.Why Work Here? Join a highly regulated, quality-focused manufacturing environment where safety, compliance, and professional growth are priorities. You will work with advanced aseptic processes and gain exposure to a broad range of pharmaceutical and medical device operations, including bulk manufacturing, filling, and packaging. The organization emphasizes strong HSE practices, thorough training, and teamwork, offering opportunities to build specialized technical skills in cGMP and aseptic processing while contributing directly to the production of healthcare products. Flexible scheduling options and regular overtime opportunities provide additional earning potential and variety in your workweek. Work Environment This role is primarily based on a second-shift schedule, Monday through Friday, with flexible start times typically between 10:00 a.m. and 12:00 p.m., working through approximately 8:00 p.m. There is regular opportunity for 5–10 hours of overtime per week, and the position may require frequent weekend work depending on production demands. There is also potential for occasional first-shift assignments, generally between 5:00 a.m. and 12:00 p.m., when needed to support production. Most work activities take place in classified aseptic manufacturing areas and require standing for extended periods while wearing full aseptic gowning for the majority of the shift. The environment is highly controlled and cGMP-compliant, with strict adherence to cleaning, sanitization, and documentation standards. The role involves moving heavy vessels and autoclave racks on wheels, handling transfer carts, and occasionally entering confined spaces. Work is performed using standard production equipment, cleaning and sanitization systems, and basic computer tools in a team-oriented, safety-focused setting. Job Type & Location This is a Contract to Hire 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 About Aerotek: We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meets their goals, skills and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role solving for companies’ construction, manufacturing and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are everything spirit to the test as your career continues to grow. Aerotek offers weekly pay, employee benefits including medical, dental & vision, life insurance, health advocacy and employee assistance programs, a 401(k) plan, and employee discounts. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Company DescriptionWe know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.
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