MS&T Specialist III
Teva Pharmaceutical Industries
Who we are
Actavis Laboratories FL, Inc is seeking a MS&T Specialist III (Davie, FL) to provide process-engineering expertise for technology transfer, from pre-validation through commercial lifecycle for modified release solid oral dosage form manufacturing including scale up, validation and lifecycle changes.
- Perform technical analysis to understand and reduce technology transfer risk, estimate cycle time, improve equipment fit, and implement required technologies.
- Design, develop and optimize process simulation techniques for process optimization and scale up.
- Work with internal and external groups to ensure technical success of technology transfer and continued cost effective manufacturing.
- Provide technical leadership to commercial operations for various unit operations including blending, sizing, compression, coating, fluid bed processing, and novel technologies.
- Perform engineering analysis of process execution, recommend opportunities for improvement with plant efficiency and risk mitigation as goals, and capture analysis in campaign summary documents.
- Provide process expertise, create and update MBR and support batch record review and analysis.
- Act as a quality events investigator for assigned projects.
- Lead documentation for equipment, lead FMEAs, recommend equipment modifications as needed for validation optimization, Analyze statistical data from qualification, product or functional specifications to determine conformance with standards and established quality requirements.
- Perform studies to support necessary equipment and system PQ's and PPQs to assure compliance in all manufacturing and support areas, analyze data using appropriate statistical tools.
- Maintain product during lifecycle (stage 3 – CPV) using appropriate statistical tools.
- Lead projects by use of appropriate project management tools.
- Provide timely updates to management on the status of various projects.
- Implement and lead use of new pharmaceutical manufacturing technologies including melt extrusion, spray drying, extrusion – spheronization, spray congealing, laser drills, nano particulates, continuous manufacturing, NIR, PAT, etcetera.
- Lead and execute material changes, process changes, and cost reduction projects.
Your experience and qualifications
- Requires a Master's degree in Pharmacy, Chemical Engineering, Pharmaceutical Engineering, Mechanical Engineering or a related field and 3 years of pharmaceutical manufacturing and/or pharmaceutical formulation and/or pharmaceutical process development and pre-validation experience.
- Employer will also accept a Bachelor's degree in the mentioned fields and 5 years of specified experience.
- Must have experience with: Various unit operations used in conventional and novel oral solid dosage manufacturing such as gral granulation, compaction, fluid bed granulation, compression, pan coating, laser drilling, and hot melt extrusion; Using validation documentation and statistical analysis; Product robustness and remediation; Complying with FDA regulation; Change Control; and Operational support.
THIS POSITION IS ELIGIBLE FOR THE EMPLOYEE REFERRAL PROGRAM.
Apply at https://www.tevapharm.com/your-career/; reference Req. 53531.
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