Catalent
Specialist III, Form/Fill
Catalent, Bloomington, Indiana, United States, 47401
Specialist III, Form/FillCatalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.Catalent’s facility in Bloomington provides a fully integrated and unique model for process development, clinical and commercial mammalian cell culture manufacturing, formulation, parenteral drug manufacturing and packaging under one roof. The award-winning facility provides clinical and commercial bulk drug substance and drug product manufacturing, including liquid and lyophilized vials, and prefilled syringes, along with an array of support services.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 Specialist III, Form/Fill role
provides direct technical support to operations area as it relates to documentation, equipment procurement, testing, operational excellence, and training. This role works collaboratively with multiple company functions to ensure production systems operate in a safe, and quality-oriented manner.This is a fulltime, onsite role, working days; Monday – Friday.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 RoleServes as the Subject Matter Expert (SME) for processes and procedures within primary manufacturing, completing work autonomouslyProposes, develops and owns process improvements related to equipment and processesCollaborates with Production Supervisors, Room Leads, and QA floor support to solve issues real timeActs as a technical expert for machine setup, troubleshooting, and maintaining overall efficiency; serves as the technical representative of Primary Manufacturing in audit activitiesDevelops training strategies for Primary Operations and provides coaching and training related to floor operations in all aspects of primary manufacturingReviews and approves documents in EDMS; owns, revises, and routes documents through EDMSExecutes other duties as assignedThe CandidateHigh School/GED required8 years’ of GMP in a pharmaceutical and/or manufacturing environment, requiredWhy You Should Join CatalentCompetitive medical benefits and 401K152 hours of PTO + 8 Paid HolidaysDynamic, fast-paced work environmentOpportunity to work on Continuous Improvement ProcessesCatalent 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.personal initiative. dynamic pace. meaningful work.
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provides direct technical support to operations area as it relates to documentation, equipment procurement, testing, operational excellence, and training. This role works collaboratively with multiple company functions to ensure production systems operate in a safe, and quality-oriented manner.This is a fulltime, onsite role, working days; Monday – Friday.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 RoleServes as the Subject Matter Expert (SME) for processes and procedures within primary manufacturing, completing work autonomouslyProposes, develops and owns process improvements related to equipment and processesCollaborates with Production Supervisors, Room Leads, and QA floor support to solve issues real timeActs as a technical expert for machine setup, troubleshooting, and maintaining overall efficiency; serves as the technical representative of Primary Manufacturing in audit activitiesDevelops training strategies for Primary Operations and provides coaching and training related to floor operations in all aspects of primary manufacturingReviews and approves documents in EDMS; owns, revises, and routes documents through EDMSExecutes other duties as assignedThe CandidateHigh School/GED required8 years’ of GMP in a pharmaceutical and/or manufacturing environment, requiredWhy You Should Join CatalentCompetitive medical benefits and 401K152 hours of PTO + 8 Paid HolidaysDynamic, fast-paced work environmentOpportunity to work on Continuous Improvement ProcessesCatalent 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.personal initiative. dynamic pace. meaningful work.
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