Job Title: Aseptic Operator
Job Description

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.

ResponsibilitiesAssist 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.Essential SkillsExperience 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.Additional Skills & QualificationsHigh 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.Work Environment

Work in a Grade A & B cleanroom environment that requires aseptic gowning but not full bunny suits. The role involves working in controlled aseptic environments while following strict gowning and hygiene protocols. Flexibility to work various shifts, including evenings, nights, weekends, and holidays, is required based on production schedules.

Pay and Benefits

The pay range for this position is $28.00 - $28.00

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 Allendale,NJ.

Application Deadline

This position will be accepting applications until Jan 3, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.