Manager MS&T Process Engineer
Date: Jan 23, 2024
Location:
Davie, United States, Florida, 33314
Company: Teva Pharmaceuticals
Job Id: 53194
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
Actavis Laboratories FL, Inc is seeking a Mgr MS&T Process Engineer (Davie, FL) to perform activities related to critical aspects of products and processes, including process development, pre-validation, and optimization of solid oral dosage forms after Abbreviated New Drug Application (ANDA) filing throughout product launch and commercial lifecycle including validation.
Execute studies with Research & Development (R&D), Laboratory Technical Services (LTS), manufacturing, and planning.
Maintain expertise related to formulation, raw material properties, and manufacturing processes.
Identify, analyze, and suggest corrective actions to optimize procedures, processes, materials, technology, and regulatory compliance issues.
Act as Subject Matter Expert (SME) for new product launches and commercial products on site.
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.
Provide continued technical leadership to commercial operations and ensure cost effective and robust manufacturing processes for various unit operations including blending, sizing, compression, coating, fluid bed processing, and novel technologies.
Contributing to business teams through innovation, strategic input, and industry knowledge to trouble shoot and achieve cost leadership.
Perform engineering analysis of process execution, recommends opportunities for improvement with plant efficiency and risk mitigation as goals, and captures analysis in campaign summary documents.
Provide process expertise in post-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.
Maintain product during lifecycle (stage 3 – CPV) using appropriate statistical tools.
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, cost reduction projects and CPV (Continued Process Verification).
Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMPs), and Standard Operating Procedures (SOPs) and Batch Record instructions.
Your experience and qualifications
Requires a Master’s degree or foreign academic equivalent in Pharmaceutical Chemistry, Pharmaceutical Sciences, Pharmaceutical Engineering, Chemical Engineering, or a related field.
Plus 5 years of experience in the job offered or 5 years in a related occupation including Process Engineer, Chemical Engineer, Technology Transfer Associate, or related pharmaceutical experience.
Will accept a Bachelor’s degree plus 7 years of experience in lieu of the required education and experience.
Position requires 3 years of experience with process validation and technology transfer.
Will accept any suitable combination of education, training, or experience as per the requirements cited herein. 40hrs/week.
THIS POSITION IS ELIGIBLE FOR THE EMPLOYEE REFERRAL PROGRAM
Apply at https://www.tevapharm.com/your-career/; reference Req. 53194.
Already Working @TEVA?
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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
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EOE including disability/veteran