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Description

The 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 • Ensures 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. • Gowning up to 10 hours per day- 4 days per week. Gowning/Aseptic Technique Experience • Reports any accidents, incidents and injuries or illnesses immediately and notifies manager of any hazards, unsafe acts or conditions in the workplace • • Ensures that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). • Knowledge of current Manufacturing Practices (GXP) guidelines. • Reports any accidents, incidents, and injuries or illnesses immediately and notifies manager of any hazards, unsafe acts or conditions in the workplace. • Prepares 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. • Takes ownership of individual training plan. • Responsible 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. • Obtaining equipment and required components for filling operations. • Follows all steps outlined in batch records, ability to actively perform all tasks being required by the batch record/ SOPs. • Ability to perform a batch record review in real time. • Ability to operate aseptically in ISO 5 Cleanrooms. • Customer/ Client Focus • Ethical Conduct, respect for others, and solidarity. • Technical Capacity to operate and troubleshoot processing equipment. • Conscientiousness for work and documentation. • Other duties and responsibilities as assigned.

Skills

batch 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

Top Skills Details

batch record,sterile processing,cleanroom,compound,Sterilization,Iso standards,Aseptic technique,Pharmaceutical,Pharmaceutical industry,Aseptic,Cgmp,Gmp environment

Additional Skills & Qualifications

• High 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. • Two years of experience working in ISO 5 areas. • Ability to handle sensitive information with a high degree of confidentiality. • Ability to work in a fast-paced environment while demonstrating excellent time management and organization skills. • Proficient in the use of standard Microsoft Office software products, including Excel, Outlook, Word • Strong organizational skills with the proven ability to prioritize. • Works with a sense of urgency while engaging and listening to experts. • Must be dependable and punctual. • Fluent in English both written and spoken.

Experience Level

Entry 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 [email protected] (%[email protected]) for other accommodation options.