Senior Engineer, Manufacturing Science and Technology (MS&T)

Company: Disability Solutions
Location: Bloomington
Posted on: November 16, 2024

Job Description:

Senior Engineer, Manufacturing Science and Technology (MS&T) Job SummaryCatalent 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.The Senior Engineer, MS&T works with clients to transfer and scale up of drug substance processes from development to the GMP space.-- This is a fulltime, onsite role, working days; Monday - Friday.-- ----This role offers a $10,000 sign on bonus.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

• Perform process technology transfer between external clients or Process Development and Drug Substance Manufacturing.
• Author and review documents including batch production records, protocols, tech transfer reports, bill of materials, process descriptions, project reports, user specifications, and summary reports.
• Perform responsibilities associated with the evaluation, alignment, and recommendation of equipment and process improvements.
• Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.
• Work cross functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other departments to effectively transfer and maintain processes in the facility.
• Perform other responsibilities to support group, site, and network-based initiatives, as required.The Candidate
  • Bachelor's degree in Science or Engineering and 3+ years of pharmaceutical industry experience, required
  • Master's degree in science and 2+ years of pharmaceutical industry experience, preferred
  • 2 years GMP or regulated industry experience, required.--
  • Experience with protein purification (chromatography, depth filtration, tangential flow filtration, etc.) at Manufacturing scale is preferred.
  • Experience at performing technical transfer of processes and scale-up is preferred.
  • Must be able to read and understand English-written job instructions and safety requirementsWhy You Should Join Catalent
    • Competitive medical benefits and 401K
    • 152 hours of PTO + 8 Paid Holidays
    • Dynamic, fast-paced work environment
    • Opportunity 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.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 , Senior Engineer, Manufacturing Science and Technology (MS&T), IT / Software / Systems , Bloomington, Indiana