Operator I, DS

　　This is a full-time, hourly position. This is a night shift 2 (on) – 2 (off), 3 (on) – 2 (off), 6:00pm – 6:30am.

　　The Drug Substance - Operations department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include solution preparation, master/working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.

　　This position is an entry level position in the Preparation Manufacturing team and is the starting point to acquiring skills and training required for a cGMP biomanufacturing environment. The Manufacturing Operator is responsible for the integrity testing, washing, sterilization, and preparation of GMP equipment(stainless steel clamps, J-tubes, scissors, gas filters, valves, etc). using a parts washer, decontamination and sterilization autoclaves, pre and post-use filter integrity testers, and several other common hand tools (Crimpers, Pliers, tubing cutters, etc.)

　　Catalent Biologics in Bloomington, Indiana is a state-of-the-art, GMP manufacturing facility, providing one million sq/ft of drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better, healthier lives. 

　　Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

　　The Role

　　Follows detailed Batch Records and procedures to prepare and test drug substance equipment and consumables.

　　Practices aseptic behavior within in a clean room environment; Safely and accurately loads and operates large machines such as parts washers and autoclaves per procedure.

　　Raises atypical observations and notifies management/quality as required; Completes routine and basic preventative maintenance of equipment; Performs equipment/room cleanings as required.

　　Performs general cleanroom housekeeping, including room and equipment cleaning(s), disposal of trash and recyclables, and adherence to 5S standards.

　　Assists in stocking and staging production suites; Addresses corrections to all executed documentation in a timely manner to support lot release.

　　Perform basic math skills (+, -, x, /, %, understand decimals)

　　Works scheduled shift and other off-shift coverage as required

　　Has basic knowledge of the principles and concepts of a discipline (e.g., Biology, Chemistry)

　　Other duties as assigned

　　The Candidate

　　High School/GED required

　　0-2 years relevant experience

　　GMP experience preferred

　　Why Join Catalent:

　　Defined career path and annual performance review and feedback process

　　Diverse, inclusive culture

　　Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

　　152 hours of paid time off annually + 8 paid holidays

　　Competitive salary with yearly bonus potential

　　Community engagement and green initiatives

　　Generous 401K match and Paid Time Off accrual

　　Medical, dental and vision benefits effective day one of employment

　　Tuition Reimbursement

　　Catalent 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 Catalent Careers (https://careers.catalent.com/us/en) 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 [email protected] . 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 [email protected] for us to investigate with local authorities.

　　California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .