Aseptic Operator

$28 - $28/Yr

Actalent - Allendale, NJ

Full-time - Entry Level

Allendale, NJ

Administrative and Support Services

About the position

We are seeking a dedicated Aseptic Operator to join our team and assist with the validation of new areas, including manufacturing equipment and processes. This role involves collaborating with cross-functional teams to troubleshoot issues, participate in aseptic process simulations, media fills, and equipment qualifications, and ensure the integrity of product quality through in-process inspections and quality control checks. The ideal candidate will adhere to strict cGMP and Good Documentation Practices, contribute to continuous improvement initiatives, and comply with all relevant policies, guidelines, and regulatory requirements.

Responsibilities

• Assist with initial and subsequent validation of new areas, including manufacturing equipment and processes.
• Collaborate with Quality Assurance, Quality Control, and Maintenance teams to troubleshoot issues and resolve deviations.
• Participate in aseptic process simulations, media fills, and equipment qualifications.
• Conduct in-process inspections and quality control checks to verify product quality.
• Complete required documentation in logbooks, forms, and batch records following cGMP and Good Documentation Practices.
• Identify opportunities to enhance processes, reduce waste, and increase efficiency as part of continuous improvement initiatives.
• Complete initial aseptic gowning and process qualification and maintain qualification to work within Grade A and Grade B cleaning environments.
• Comply with policies, guidelines, and regulatory requirements of the Quality System and applicable cGMPs.
• Perform other duties as required and assigned by management.

Requirements

• Experience in cleanroom environments, specifically Grade A & B cleanrooms.
• 4-6 years of experience in aseptic techniques and filling rooms.
• Experience with troubleshooting and laboratory manufacturing processes.
• Knowledge of batch record documentation and cGMP practices.

Nice-to-haves

• High school diploma or equivalent; additional technical or vocational education is a plus.
• Minimum 1 year of experience in the pharmaceutical, biopharma, or biotech industry within aseptic cleanroom environments.
• Knowledge of aseptic gowning techniques, cleanroom protocols, and cGMP.
• Ability to read and comprehend work instructions and standard operating procedures.
• Ability to understand equipment alarms and escalate as necessary.
• Exceptional attention to detail, accuracy, and documentation skills.
• Good communication skills and ability to work collaboratively in a team-oriented environment.
• Flexibility to work in shifts, including evenings, nights, weekends, and holidays as required by production schedules.

Benefits

• 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)