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Process Engineer

Date: Aug 4, 2022

Location: Davie, Florida, US, 33314

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

 

We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com.

Job Description

POSITION SUMMARY
    
Innovate, optimize and troubleshoot new product introduction and commercial manufacturing processes throughout lifecycle to improve process/product robustness, reduce cost and eliminate waste in oral solid dosage manufacturing of modified release products using conventional and novel technologies. 

Design, develop and optimize process simulation techniques for process optimization and scale up.

 

ESSENTIAL AREAS OF RESPONSIBILITY 

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary.  Any non-essential functions are assumed to be included in other related duties or assignments. 

  • Providing 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
  • Responsible for completing all training requirements and maintaining 100% compliance with all assignments   
  • Responsible to comply with company goals based on departmental assigned goals
  • 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 (cGMP’s), and Standard Operating Procedures (SOP’s) instructions
  • Responsible for performing additional related duties as assigned

Qualifications

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered. 

 

Education/Certification/Experience:

  • A Masters or PhD degree in Chemistry, Pharmaceutical Engineering, Pharmaceutical Manufacturing, or Pharmaceutical Technology is required
  • Proficiency with statistics (using JMP or Minitab), SPC, NIR, 
  • Experience and certification in commercialization of PAT or certification in project management
  • Experience using Excel for data mining and analysis is required
  • Experience with novel manufacturing technologies (at least two) melt extrusion, extrusion spheronization, spray drying, spray congealing, laser drills, nano particulates, continuous manufacturing, NIR or PAT
  • Masters - minimum 7 years’ experience; out of which at least three years in modified release oral solids manufacturing; PhD – minimum research work in any of novel manufacturing technologies mentioned above and exposure to pharmaceutical manufacturing.

 

Skills/Knowledge/Abilities:

  • Excellent verbal, written, and interpersonal skills required 
  • Understanding of various unit operations used in conventional and novel oral solid dosage manufacturing
  • Comply with FDA regulations at all times
  • Skill levels in MS Office including proficiency in Word, PowerPoint, Excel and SharePoint
  • Must be able to maintain the highest levels of confidentiality, integrity and discretion

 

Problem Solving:

  • Able to identify solutions to general problems through collaboration and creativity
  • Proactively works on problems of complex scope 
  • Seeks out all resources when selecting methods and techniques for obtaining results
  • Acts independently and proactively to recommend and administer methods and procedures for problem resolution

 

Travel Requirements:

N/A

 

Physical Requirements:

Constant:

  • Sitting for extended periods of time at work station or mobile equipment
  • Using fingers to perform activities such as picking, pinching or typing
  • Repetitive Motions (frequent motions of the wrists, hands and/or fingers)

 

Frequent:

  • Walking to move short distances quickly and frequently

 

Occasional:

  • Standing for extended periods of time at work station or equipment

 

Visual Acuity:

  • Close visual acuity to perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes
  • Visual acuity to perform activities such as operating machines (i.e. lathes and drill presses) where the seeing job is at or within arm’s reach

 

Working Environment

  • Fast paced environment
  • Able to manage multiple priorities and ensure appropriate follow-ups
  • Highly organized and excellent time and project management skills with the ability to juggle a wide range
  • Ability to work under pressure and meet deadlines
  • Low to loud noise level exposure
  • 24/7 Support based on business needs

Teva Pharmaceuticals USA requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, however, Teva will consider requests for reasonable accommodations.

Function

Manufacturing

Sub Function

Technical Transfer

Reports To

In process of validation

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

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.


Nearest Major Market: Fort Lauderdale
Nearest Secondary Market: Miami