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Sterile Technician
- Actalent (Newark, NJ)
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Job Title: Manufacturing Support AssociateJob Description
The Manufacturing Support Associate is responsible for maintaining GMP readiness of cleanrooms by executing routine and ad-hoc facility sanitization, performing viable and non-viable environmental monitoring, and supporting material/equipment/product flow throughout the facility. This detail-oriented role is critical for contamination control and ensuring patient safety.
Responsibilities
+ Perform routine scheduled and ad hoc cleaning of classified cleanrooms in accordance with SOPs, cGMP requirements, and regulatory expectations.
+ Accurately complete cleaning logs and documentation to ensure GDP compliance.
+ Support inspection readiness by maintaining cleanroom standards and promptly addressing deviations.
+ Conduct viable and non-viable environmental monitoring, including settle plates, contact plates, active air sampling, and particle counts across classified areas.
+ Document environmental monitoring results in accordance with SOPs, ensuring accurate data collection and traceability.
+ Coordinate with Quality Control for submission, tracking, and follow-up of environmental monitoring samples.
+ Safely transfer raw materials, consumables, drug products, and equipment throughout the facility, including classified locations.
+ Support material staging and preparation to enable timely manufacturing operations.
+ Assist production staff with ancillary support tasks as needed, such as cryopreservation transfer tasks.
+ Adhere strictly to GMP, GDP, and safety requirements during all activities.
+ Comply with all local policies and SOPs governing tasks performed.
+ Maintain training status, including aseptic gowning qualification and requalification.
+ Identify and escalate any deviations or anomalies observed during cleaning, environmental monitoring, or material handling.
+ Participate in training, audits, and continuous improvement initiatives such as 5S/Kaizen to sustain a culture of quality and compliance.
Essential Skills
+ Associate's degree in the sciences.
+ 1 year of GMP aseptic experience, ideally in Grade B ISO 5.
+ Experience in environmental monitoring, aseptic techniques, microbiology, laboratory, and biology.
+ Knowledge of aseptic technique, contamination control principles, and cleanroom operations.
+ Familiarity with environmental monitoring methods and good documentation standards.
+ Strong attention to detail with proven ability to follow SOPs and GDP requirements.
+ Strong teamwork and communication skills with flexibility to support cross-functional needs.
Additional Skills & Qualifications
+ Bachelor’s degree in a science-based discipline, such as biology, chemistry, or biotechnology.
+ Prior experience with cleanroom sanitization, environmental monitoring execution, and/or materials handling is strongly preferred.
Work Environment
This role is part of a leading US-based cell therapy contract development and manufacturing organization (CDMO) that specializes in developing, manufacturing, and releasing autologous and allogeneic cell therapy products for clinical and commercial supply. The company operates from two U.S.-based manufacturing facilities, offering the agility and entrepreneurial spirit of a specialist CDMO, combined with the global expertise and resources of a global leader in the pharmaceutical and biotechnology sectors. The work schedule requires shift work, including off-shift hours, weekends, and holidays as needed to meet production demands. The primary location is the Princeton, NJ facility, with travel to the Newark, NJ facility up to 50% during peak periods based on business needs.
Job Type & Location
This is a Contract to Hire position based out of Princeton, New Jersey.
Pay and Benefits
The pay range for this position is $30.00 - $32.00/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 Newark,NJ.
Application Deadline
This position is anticipated to close on Nov 11, 2025.
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.
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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.
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