Branchburg, NJ, 08876, USA
4 days ago
Biologic Operator I
Job Title: Biologic Operator IJob Description We are seeking an entry-level Biologic Operator I to join our team. The successful candidate will play a crucial role in the production of highly sensitive and expensive Biological Parenteral products. This position involves working in aseptic high-level silent environments, performing repetitive tasks such as syringe inspection, and operating various equipment. The role requires a biology degree and 1-2 years of working experience. Responsibilities + Perform repetitive tasks such as syringe inspection in aseptic environments. + Work in cold rooms with temperatures ranging from 15 to 25 degrees Celsius and occasionally in colder rooms of 2 to 8 degrees Celsius. + Handle the cleaning, preparation, and sterilization of manufacturing equipment. + Formulate biological parenteral products aseptically. + Perform process samples such as pH, density, and osmolality tests. + Inspect equipment to verify operational parameters. + Carry out cleaning operations, pressure testing, sterilization, and equipment integrity checks. + Monitor processes through computerized systems and visual inspection. + Receive and verify materials for final product manufacture. + Participate in qualification and validation activities of the SVP area. + Maintain detailed records of operations, batch records, and logbooks. + Handle and dispose of hazardous and non-hazardous materials per established procedures. + Use required personal protective equipment (PPE) and report unsafe conditions. + Diagnose and resolve equipment and process issues using systems such as HMI and PLC. + Assist in the control, management, and disposal of waste to ensure compliance with regulations. Essential Skills + Biology degree + 1-2 years of working experience + Experience with aseptic techniques + Knowledge of ISO standards + Familiarity with FDA regulations + Proficiency in SAP + Strong documentation skills + Experience with cycle counts and audits + Understanding of 5S methodology Additional Skills & Qualifications + Ability to tolerate sitting in the same position for 6.5 hours a day with 55 minutes of consecutive work and 5 minutes of visual rest. + Capability to work in low light conditions. + Experience in working with cGMPs, GDP, and USP environments. Work Environment This role involves working Sunday to Wednesday from 4:00 AM to 2:30 PM in a regulated environment adhering to cGMPs, GDP, ISO, and FDA standards. The work environment is an aseptic high-level silent area with cold room conditions, requiring the use of personal protective equipment (PPE). Candidates must be able to tolerate sitting for extended periods and work in low light and varying temperature conditions. Pay and Benefits The pay range for this position is $20.00 - $22.00 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 Branchburg,NJ. Application Deadline This position will be accepting applications until Jan 10, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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