Description
\t\t\t\t\tThe Sterile Production Technician will be responsible for conducting cGMP manufacturing of sterile pharmaceutical dosage forms. Under the direction of the Production Supervisor, the Sterile Production Technician will work hands on, under ISO7 and ISO5 area, with a variety of manufacturing production equipment and technologies. Daily responsibilities vary and include production equipment set up, weighing of materials, manufacturing of batches, sterilization of product, submitting samples, performing filling operations under ISO5 environment•\tEnsures that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). Knowledge of current Good Manufacturing Practices (GXP) guidelines.•\tGowning up to 10 hours per day- 4 days per week. Gowning/Aseptic Technique Experience•\tReports any accidents, incidents and injuries or illnesses immediately and notifies manager of any hazards, unsafe acts or conditions in the workplace•\t•\tEnsures that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). •\tKnowledge of current Manufacturing Practices (GXP) guidelines.•\tReports any accidents, incidents, and injuries or illnesses immediately and notifies manager of any hazards, unsafe acts or conditions in the workplace.•\tPrepares for production run by reviewing the production schedule; identifying batch specific requirements; setting up the filling lines as per batch record instructions and applicable SOPs.•\tTakes ownership of individual training plan.•\tResponsible for reviewing all documentation including executed batch records and logbooks in “Real Time and Right First Time” and demonstrating error free documentation. Immediately reports errors or discrepancies to management.•\tObtaining equipment and required components for filling operations.•\tFollows all steps outlined in batch records, ability to actively perform all tasks being required by the batch record/ SOPs.•\tAbility to perform a batch record review in real time.•\tAbility to operate aseptically in ISO 5 Cleanrooms.•\tCustomer/ Client Focus•\tEthical Conduct, respect for others, and solidarity.•\tTechnical Capacity to operate and troubleshoot processing equipment.•\tConscientiousness for work and documentation. •\tOther duties and responsibilities as assigned.
\t\t\t\t\tSkills
\t\t\t\t\tbatch record, sterile processing, cleanroom, compound, Sterilization, Iso standards, Aseptic technique, Pharmaceutical, Pharmaceutical industry, Aseptic, Cgmp, Gmp environment, Microbiology, Gmp, Production, Chemical, Manufacturing environment, Filling, Manufacturing process, Iso quality, Iso audit
\t\t\t\t\tTop Skills Details
\t\t\t\t\tbatch record,sterile processing,cleanroom,compound,Sterilization,Iso standards,Aseptic technique,Pharmaceutical,Pharmaceutical industry,Aseptic,Cgmp,Gmp environment
\t\t\t\t\tAdditional Skills & Qualifications
\t\t\t\t\t•\tHigh School diploma or BS degree a plus with 2 years -Pharma/Biotech Manufacturing Support and 1 year- within Clean Room environments and some technical certification is desired in related field. •\tTwo years of experience working in ISO 5 areas.•\tAbility to handle sensitive information with a high degree of confidentiality.•\tAbility to work in a fast-paced environment while demonstrating excellent time management and organization skills.•\tProficient in the use of standard Microsoft Office software products, including Excel, Outlook, Word•\tStrong organizational skills with the proven ability to prioritize.•\tWorks with a sense of urgency while engaging and listening to experts.•\tMust be dependable and punctual. •\tFluent in English both written and spoken.
\t\t\t\t\tExperience Level
\t\t\t\t\tEntry Level
Pay and Benefits
The pay range for this position is $25.00 - $28.00/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 Ledgewood,NJ.
Application Deadline
This position is anticipated to close on Sep 16, 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 actalentaccommodation@actalentservices.com for other accommodation options.