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Operator I, Form/Fill

Company: Disability Solutions
Location: Bloomington
Posted on: July 2, 2024

Job Description:

Operator I, Form/FillSummary:Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients.-- The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA.-- Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.Working for Catalent Biologics is an opportunity to join an entrepreneurial team.-- Catalent Biologics is making significant investments in people and capabilities. --This is a unique opening to join a small, fast-growing business, backed by a global public company.-- People joining our team will have the opportunity for career development as our business continues to grow and expand.-- Catalent employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart, and lung diseases as well as Alzheimer's.Drug Product Primary Manufacturing produces sterile pharmaceuticals. The department includes equipment preparation, product formulation, material staging, and aseptic filling. Product in this area is filled into vials, syringes, or cartridges inside sterile isolator barriers.-- The sterile barrier isolator provides a physical barrier between the manufacturing equipment and the personnel controlling the machine. The Drug Product Primary Manufacturing area is a cleanroom environment. Personnel working in this area are required to wear scrubs and/or coveralls, gloves, hairnet, safety glasses, and steel toed shoes.The Role:--

  • Has developed operational skills through formal training or work experience
  • Demonstrate mathematical skills, including the ability to perform addition, subtraction, multiplication, division, significant figures and unit conversions
  • Reports safety and quality concerns and recommends improvement
  • Works within established procedures with a moderate degree of supervision
    • Daily execution of required clean room sanitizations
    • Electronic verification of allocated materials for processing
    • Perform area room clearances prior to batch execution
    • General housekeeping items (waste collection, stocking, etc) within production areas
    • Executes work while following Good Documentation Practices and Aseptic BehaviorFormulation -
      • Performing standard calculations to achieve desired weight/mixture of drug products
      • Aliquoting liquids and powders from one vessel to another per batch record instructions
      • Performing sterile filtration and integrity testing of product filters
      • Cleaning and sterilizing tanks with automated equipment (i.e. CIP/SIP)Filling -
        • Performing in-line sterile filtration and integrity testing of product filters
        • Set up of filling equipment which includes part installation on filling line
        • Run and troubleshoot complex machinery through Human Machine Interface (HMI)
        • Collect and deliver samples throughout execution per sampling plan
        • Perform unit counts post batch execution
        • Performing quality checks of finished units during fill processingPrep -
          • Identifying and retrieving applicable equipment needed for batch execution
          • Wash/Clean/Sterilize equipment using automated and manual process
          • Prepare small and large equipment assemblies
          • Post batch activities such as reconciliation and filter integrity testing-- Material Staging (Pit Crew)
            • Staging/Sanitization of materials in classified areas
            • Coordinating deliveries of materials with Supply Chain
            • Electronic verification of material movements for processing
            • Delivering finished product to appropriate storage conditionsThe Candidate
              • High School/GED
              • 0-2 years of experience
              • GMP experience preferredPosition Benefits:
                • 152 hours PTO & 8 Holidays
                • Medical, Dental & Vision Benefits and 401k
                • Tuition ReimbursementCatalent offers rewarding opportunities to further your career!-- Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.--Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.------personal initiative. dynamic pace. meaningful work.Visit to explore career opportunities.Catalent is an Equal Opportunity Employer, including disability and veterans.If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.--------Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice .

Keywords: Disability Solutions, Bloomington , Operator I, Form/Fill, Other , Bloomington, Indiana

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