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Process Engineer Technical Operation

Chestnut Ridge United States

2 months ago


Years of Experience

10 - 15 years

Workplace Type

On-site

Seniority Type

Senior

Industry

Pharmaceuticals


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Skills

MinitabInvestigation Report WritingTech Transfer ActivitiesStatistical Data AnalysisChange Control Implementation

Contact our TA to know more about the job

Shamia Pawaskar

Talent Advocate at WhiteCrow


Description

About our client

Our client is a leading Indian pharmaceutical company, headquartered in Bengaluru and a footprint across 100 countries. The company manufactures pharmaceutical products, over-the-counter drugs, and nutraceuticals. They operate two business verticals, Regulated Markets and Emerging Markets. Their manufacturing footprint covers 8 manufacturing facilities in 4 continents, including 5 US FDA approved facilities and a dedicated R&D facility in India with global filing capabilities.

The company partners with generic companies in US and Canada, to supply retail and hospital generics in injectable products and soft gels. In European markets, it has long-term relationships for the development of projects and supply agreements. In Australia and New Zealand, the company is engaged in manufacturing and supply of soft gels and value-added manufacturing.


Job description

Responsibilities


  • Perform Tech Transfer activities for CMO products with minimum guidelines specifically for liquid, powder filling, soft gel and semi solid that consist of designing, planning, conducting review of pre-formulation, formulation, and process development activities as well as scale-up trials.
  • Prepare and execute engineering study protocols, manufacturing and packaging experimental / feasibility study / validation batch records and protocols and complete interim and / or final summary reports for marketed and new products. 
  • Analyze statistical data from qualification, product or functional specifications to determine conformance with standards and established quality requirements.
  • Write and execute experimental and validation protocols as per related SOPs and assure that acceptance criterion related to experimental and validation protocols are met.
  • Write and execute experimental and validation reports as per related SOPs and assure that acceptance criterion related to experimental and validation reports are met.
  • Initiate change control for new products, site transfer products and changes related to the process improvement with appropriate justification. 
  • Lead investigations, write investigation reports with appropriate scientific understanding, as required upon failures to meet protocol acceptance criteria.
  • Author and review investigation reports, protocols, batch records and CMC documentation.
  • Lead projects by use of appropriate project management tools, provide timely updates to management on the status of various projects.
  • Lead and execute material changes, process changes and cost reduction projects.
  • Performs other related duties as assigned.
  • Provide technical training and assistance to others.


Requirements:


  • A Bachelor’s in Chemical Engineering preferred.
  • Experience with manufacturing liquid, cream, gel, powder filling, soft gel etc preferred.
  • Proficiency with statistics (using Minitab) preferred.
  • Experience using Excel for data mining and analysis is must.

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Contact our TA to know more about the job

Shamia Pawaskar

Talent Advocate at WhiteCrow


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