Engineer, Manufacturing Science and Technology
Position Summary
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent Greendale site is one of Catalent's gummy technology development and manufacturing facilities in North America. The site manufactures organic and vegan-based nutraceuticals via confection to enhance wellness for all consumers. Simply put - we make healthy gummies. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.
The Engineer, Manufacturing Sciences and Technology (MS&T) is responsible for supporting GMP manufacturing operations as a project leader to commercialize new products and optimize commercial manufacturing processes. The Engineer, MS&T assists in translating client and process development information into cGMP process implementation.
Monday-Friday 8 AM-5 PM. This role is 100% on-site in Greendale, Indiana.
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
Collaborate with GMP manufacturing and Product Development project teams as the MS&T project lead and subject matter expert in Starch Mogul Process.
Support the conversion of client strategies into tactical execution plans for successful technology transfers and commercial manufacturing. Collect and analyze process data for internal and client review.
Act as the team leader for process and product investigations, and draft comprehensive investigation reports.
Lead MS&T tech transfer projects from both Catalent Process Development and external clients into GMP manufacturing. Author technical transfer documents and standard operating procedures (SOPs) to support GMP manufacturing projects.
Work with R&D, QA, and Operations to evaluate and assess project/program data for implementing products and technologies into commercial production; establish process improvements based on analysis of trends and study data.
Address deviations, and customer complaints; participate in determining and implementing corrective actions.
Ensure robustness of commercial product manufacturing processes.
Prepare MS&T reports, protocols, process validations, and verifications, while delivering technical expertise and support for a range of projects. Coordinate with Project Management to achieve MS&T project milestones by attending regular and ad hoc meetings.
Other duties as assigned.
The Candidate
B.S. in Engineering, Chemistry, Biology, Life Sciences or a related field with 2+ years of experience in the nutraceutical, pharmaceutical, or biotechnology manufacturing industry; OR M.S. in Chemical Engineering, Chemistry, Biology, Life Sciences or a related field with 1+ year of experience.
Experience with established food or confectionary manufacturers, CMOs, or similar client-based environments is preferred.
Knowledge of GMPs, FDA regulations, and documentation procedures required.
Experience in quality systems regulations.
Familiarity with Lean Six Sigma methodologies and analytical/problem-solving capabilities.
The employee must be able to lift and/or move up to 50 pounds. While performing the duties of this job, the employee is required to use hands to finger, handle, or feel and is frequently required to stand, walk, reach with hands and arms, stoop, kneel, crouch, or crawl, and talk or hear. The employee is required to sit, climb, or balance and taste or smell.
Why You Should Join Catalent
Defined career path and annual performance review and feedback process.
152 hours of PTO + 8 paid holidays.
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
Tuition Reimbursement - Let us help you finish your degree or earn a new one!
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.
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 DisabilityAccommodations@catalent.com . 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 HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .
