Overview
The Engineer, Manufacturing Sciences and Technology (MS&T) is responsible for supporting GMP manufacturing operations as a project lead 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. This role is on-site in Greendale, Indiana, Monday–Friday 8 AM–5 PM.
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 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
Education and experience : 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.Preferred experience : Experience with established food or confectionary manufacturers, CMOs, or similar client-based environments is preferred.Regulatory knowledge : Knowledge of GMPs, FDA regulations, and documentation procedures required. Experience in quality systems regulations.Skills : Familiarity with Lean Six Sigma methodologies and analytical / problem-solving capabilities.Physical requirements : The employee must be able to lift and / or move up to 50 pounds and be able to stand, walk, reach with hands and arms, stoop, kneel, crouch, or crawl, and talk or hear. May be required to sit, climb, or balance and to 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 is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process, please contact DisabilityAccommodations@catalent.com with the job number, title and location.
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