Job Title: Aseptic Operator

Job Description

• We are seeking an Aseptic Operator to assist with the validation of new areas, including manufacturing equipment and processes.
• The successful candidate will collaborate with cross-functional teams to troubleshoot issues, resolve deviations, and participate in aseptic process simulations, media fills, and equipment qualifications.
• In this role, you will conduct in-process inspections, quality control checks, and complete necessary documentation while adhering to cGMP and Good Documentation Practices.
• Additionally, you will contribute to continuous improvement initiatives and maintain qualification to work within Grade A and Grade B cleaning environments.

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 logbook, form, and batch record documentation as required, adhering to cGMP and Good Documentation Practices.
• Contribute to continuous improvement initiatives by identifying opportunities to enhance processes, reduce waste, and increase efficiency.
• 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 cGMPs.
• Perform other duties as required and assigned by management.

Essential Skills

• Experience working in Grade A and B aseptic clean rooms.
• Minimum of 2-3 years of experience in a pharmaceutical, biopharma, or biotech industry.
• 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.
• Ability to work in a controlled aseptic environment, following gowning and hygiene protocols.
• Good communication skills and the ability to work collaboratively in a team-oriented environment.

Additional Skills & Qualifications

• High school diploma or equivalent; additional technical or vocational education is a plus.
• Minimum of 1 year of experience working in the pharmaceutical/biopharma/biotech industry and within aseptic clean room environments.
• Flexibility to work in shifts, including evenings, nights, weekends, and holidays, as required by production schedules.

Work Environment

• This position requires working in Grade A and B cleanrooms, which involves aseptic gowning but not a full bunny suit.
• The role includes working shifts, including evenings, nights, weekends, and holidays, as necessary to meet 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 Parsippany,NJ.

Application Deadline

This position will be accepting applications until Jan 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.

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.

Salary : $28